FDA · SEC
Complete Response Letter Tracker
Companies that received an FDA Complete Response Letter, with what the letters and the companies' own filings say, quoted and linked to source.
Atlas: all 456 complete response letters as an interactive workspace: cohorts, comparisons, time to approval, recurring objections. Open the atlas →
Deep research: what happened after an FDA decision, reconstructed question by question for 5 companies. Read the deep research →
| Company | Product | Application | Letters | Letter dates | Topics |
|---|---|---|---|---|---|
| ITM Solucin GmbH | MPA | NDA 218705 | 1 | Aug 7, 2026 | Facility inspections |
| Apiject Systems Corp. | glycopyrrolate | NDA 219107 | 1 | Jul 21, 2026 | |
| Elevar Therapeutics, Inc. | rivoceranib | NDA 216586 | 3 | Jul 9, 2026 Mar 20, 2025 May 16, 2024 | Facility inspections |
| Jiangsu Hengrui Pharmaceuticals Co., Ltd. | — | BLA 761308 | 3 | Jul 9, 2026 Mar 20, 2025 May 16, 2024 | Facility inspections |
| Ascelia Pharma AB | — | NDA 220544 | 1 | Jul 2, 2026 | |
| Ipsen Biopharm Ltd. | relabotulinumtoxin A | BLA 761311 | 1 | Jun 29, 2026 | Facility inspections |
| Unicycive Therapeutics Inc. | oxylanthanum carbonate | NDA 218607 | 2 | Jun 29, 2026 Jun 27, 2025 | Facility inspections |
| Evergreen Theragnostics, Inc. | — | NDA 216900 | 1 | Jun 26, 2026 | Facility inspections |
| Swedish Orphan Biovitrum AB (publ) | sirolimus | BLA 761438 | 1 | Jun 26, 2026 | Facility inspections |
| Tanvex BioPharma USA, Inc. | TX05 | BLA 761266 | 5 | Jun 23, 2026 Jan 3, 2025 Feb 14, 2023 May 20, 2021 Sep 24, 2019 | Facility inspections |
| Achieve Life Sciences, Inc. | cytisinicline | NDA 218995 | 1 | Jun 20, 2026 | Facility inspections |
| Tris Pharma, Inc. | oxybate | NDA 220138 | 2 | Jun 15, 2026 Jul 25, 2018 | Facility inspections |
| Bridge Regulatory Affairs, LLC | octreotide hydrochloride extended- release | NDA 218600 | 2 | Jun 10, 2026 Oct 21, 2024 | Facility inspections |
| Xspray Pharma AB | nilotinib | NDA 217644 | 3 | Jun 4, 2026 Oct 7, 2025 Jul 25, 2024 | Facility inspections |
| Cingulate Therapeutics, LLC | dexmethylphenidate hydrochloride | NDA 220283 | 1 | May 29, 2026 | Facility inspections |
| Ocuvex Therapeutics, Inc. | brimonidine tartrate | NDA 217363 | 1 | May 15, 2026 | Facility inspections |
| Grace Therapeutics U.S., Inc. | nimodipine | NDA 220304 | 1 | Apr 23, 2026 | Facility inspections |
| AbbVie Inc. | AGN-151586 | BLA 761459 | 3 | Apr 22, 2026 Jun 18, 2024 Mar 17, 2023 | Facility inspections |
| Eagle Pharmaceuticals, Inc. | Fulvestrant | NDA 220045 | 1 | Apr 13, 2026 | Facility inspections |
| Replimune, Inc. | vusolimogene oderparepvec | 2 | Apr 10, 2026 Jul 21, 2025 | ||
| Telix Pharmaceuticals (US) Inc. | — | BLA 761401 | 2 | Apr 10, 2026 Apr 25, 2025 | Facility inspections |
| Aldeyra Therapeutics, Inc. | Reproxalap | NDA 216442 | 2 | Mar 16, 2026 Apr 2, 2025 | Facility inspections |
| Rosemont Pharmaceuticals Holdings, Inc. | valacyclovir | NDA 220140 | 1 | Mar 5, 2026 | Facility inspections |
| Ferring Pharmaceuticals Inc. | progesterone | BLA 761253 | 5 | Feb 27, 2026 Nov 23, 2016 Jan 30, 2015 Jan 30, 2013 Apr 22, 2010 | Facility inspections |
| Fresenius Kabi USA, LLC | MSB11456 | NDA 215818 | 5 | Feb 27, 2026 Feb 27, 2026 Apr 25, 2025 Dec 11, 2024 May 31, 2023 | Facility inspections |
| Amphastar Pharmaceuticals, Inc. | — | BLA 761403 | 2 | Feb 26, 2026 Feb 17, 2017 | Facility inspections |
| Disc Medicine, Inc. | bitopertin | NDA 220707 | 1 | Feb 13, 2026 | |
| REGENXBIO, Inc. | clemidsogene lanparvovee | 1 | Feb 7, 2026 | Facility inspections | |
| Aquestive Therapeutics Inc. | dibutepinephrine | NDA 219870 | 1 | Jan 30, 2026 | |
| Corcept Therapeutics | relacorilant | NDA 219398 | 1 | Jan 28, 2026 | |
| Pierre Fabre Pharmaceuticals Inc. | tabelecleucel® | 1 | Jan 9, 2026 | ||
| Dr. Reddy’s Laboratories, Inc. | AVT03 | BLA 761471 | 12 | Dec 30, 2025 Oct 16, 2025 Apr 19, 2024 Apr 18, 2022 Nov 6, 2020 May 21, 2020 Nov 20, 2019 May 3, 2019 Jul 24, 2018 Aug 30, 2016 May 4, 2016 Dec 17, 2014 | Facility inspections |
| Outlook Therapeutics, Inc. | bevacizumab-vikg | BLA 761320 | 2 | Dec 30, 2025 Aug 27, 2025 | Facility inspections |
| Genzyme Corporation | tolebrutinib | NDA 219624 | 1 | Dec 23, 2025 | |
| MedicaSafe, Inc. | — | NDA 220184 | 1 | Dec 22, 2025 | |
| GlaxoSmithKline LLC | Exdensur lepemokimab-ulaa | BLA 761458 | 2 | Dec 16, 2025 Oct 23, 2025 | |
| LIB Therapeutics, Inc. | Lerochol | BLA 761427 | 1 | Dec 12, 2025 | |
| Sandoz Inc. | EG12014 | BLA 761271 | 3 | Dec 9, 2025 Dec 5, 2024 Jun 24, 2016 | Facility inspections |
| Alvotech USA Inc. | AVTO5 | BLA 761461 | 6 | Nov 26, 2025 Nov 24, 2025 Oct 31, 2025 Oct 11, 2023 Jun 28, 2023 Dec 20, 2022 | Facility inspections |
| Accord Healthcare Inc. | bendamustine hydrochloride | NDA 216987 | 7 | Nov 6, 2025 Dec 5, 2024 May 10, 2024 Apr 17, 2024 Mar 7, 2024 Jan 30, 2024 Apr 30, 2021 | Facility inspections |
| Biohaven Therapeutics, Ltd. | troriluzole | NDA 210862 | 1 | Nov 4, 2025 | Facility inspections |
| Shanghai Auzone Biological Technology Co., Ltd. | — | NDA 219846 | 1 | Oct 23, 2025 | |
| SYDNEXIS Inc. | atropine sulfate | NDA 219694 | 1 | Oct 22, 2025 | |
| NeuroDerm, Ltd. | carbidopa levodopa | NDA 218317 | 2 | Oct 21, 2025 May 24, 2024 | Facility inspections |
| AstraZeneca Pharmaceuticals LP | anifrolumab | BLA 761451 | 1 | Oct 10, 2025 | |
| Sentynl Therapeutics, Inc. | copper histidinate | NDA 211241 | 1 | Sep 30, 2025 | Facility inspections |
| Biogen, Inc. | — | NDA 209531 | 1 | Sep 22, 2025 | |
| Scholar Rock, Inc. | — | BLA 761463 | 1 | Sep 22, 2025 | Facility inspections |
| Saol International Development Limited | sodium dichloroacetate | NDA 218679 | 1 | Aug 27, 2025 | |
| Vyluma, Inc. | atropine sulphate | NDA 217711 | 1 | Aug 27, 2025 | Facility inspections |
| PTC Therapeutics, Inc. | vatiquinone | NDA 220049 | 1 | Aug 18, 2025 | |
| Immedica Pharma AB | — | BLA 761211 | 1 | Aug 6, 2025 | |
| Accord BioPharma Inc. | INTP1 | BLA 761147 | 5 | Aug 5, 2025 Jun 26, 2025 Mar 13, 2025 Oct 29, 2024 Apr 5, 2024 | Facility inspections |
| Conjupro Biotherapeutics Inc. | irinotecan liposome | NDA 218923 | 2 | Jul 30, 2025 Oct 10, 2024 | Facility inspections |
| Regeneron Pharmaceuticals, Inc. | — | BLA 761303 | 5 | Jul 30, 2025 Aug 20, 2024 Mar 22, 2024 Mar 22, 2024 Jun 27, 2023 | Facility inspections |
| Teva Pharmaceuticals, Inc. | TVB-009 | BLA 761385 | 2 | Jul 30, 2025 May 27, 2016 | Facility inspections |
| Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc. | — | NDA 205508 | 1 | Jul 28, 2025 | Facility inspections |
| Capricor, Inc. | deramiocel | 1 | Jul 9, 2025 | Facility inspections | |
| Ultragenyx Pharmaceutical Inc. | rebisufligene etisparvovec | 1 | Jul 7, 2025 | Facility inspections | |
| Sun Pharmaceutical Industries Limited | nilotinib | NDA 215644 | 4 | Jun 25, 2025 Oct 25, 2024 May 23, 2017 Nov 24, 2015 | Facility inspections |
| Cipla USA, Inc. | — | NDA 210168 | 2 | Jun 20, 2025 Mar 22, 2024 | Facility inspections |
| ResQ Pharma | — | NDA 217382 | 1 | Jun 2, 2025 | |
| Chemo Research, S.L. | dienogest | NDA 219029 | 1 | May 29, 2025 | |
| Stealth BioTherapeutics Inc. | elamipretide | NDA 215244 | 1 | May 15, 2025 | Facility inspections |
| University of California San Francisco | Floretyrosine F | NDA 218353 | 1 | Apr 25, 2025 | |
| Amneal EU, Limited | phenylephrine hydrochloride | NDA 218345 | 2 | Apr 2, 2025 Jul 1, 2024 | Facility inspections |
| Milestone Pharmaceuticals USA, Inc. | etripamil | NDA 218571 | 1 | Mar 27, 2025 | |
| CELLTRION, Inc. | Steqeyma | BLA 761377 | 6 | Mar 26, 2025 Dec 17, 2024 Sep 30, 2024 Jun 27, 2024 Mar 30, 2018 Feb 28, 2018 | Facility inspections |
| Seikagaku Corporation | — | BLA 761393 | 1 | Mar 11, 2025 | Facility inspections |
| Laurus Generics, Inc. | — | NDA 217719 | 1 | Mar 10, 2025 | |
| SFJ Pharmaceuticals, Inc. | — | BLA 761290 | 1 | Jan 31, 2025 | Facility inspections |
| Hospira, Inc. | Daptomycin | NDA 219112 | 5 | Jan 17, 2025 Mar 19, 2018 Feb 22, 2018 Nov 3, 2017 Apr 26, 2017 | Facility inspections |
| Atara Biotherapeutics, Inc. | tabelecleucel® @ | 1 | Jan 15, 2025 | ||
| OWP Pharmaceuticals, Inc. | — | NDA 218879 | 1 | Jan 3, 2025 | |
| Hikma Pharmaceuticals USA Inc. | phenobarbital sodium | NDA 219357 | 4 | Dec 23, 2024 Oct 21, 2024 Jan 23, 2024 Feb 28, 2020 | |
| Lexicon Pharmaceuticals, Inc. | sotagliflozin | NDA 210934 | 1 | Dec 20, 2024 | |
| Zealand Pharma US, Inc. | glepaglutide | NDA 218828 | 2 | Dec 19, 2024 Oct 8, 2024 | Facility inspections |
| Janssen Biotech, Inc. | amivantamab hyaluronidase | BLA 761433 | 1 | Dec 13, 2024 | Facility inspections |
| Meitheal Pharmaceuticals Inc. | fosfomycin | NDA 212271 | 1 | Dec 11, 2024 | Facility inspections |
| Applied Therapeutics, Inc. | govorestat | NDA 219195 | 1 | Nov 27, 2024 | |
| Astellas Pharma US, Inc. | IZERVAY | NDA 217225 | 3 | Nov 15, 2024 Jan 4, 2024 Aug 28, 2017 | Facility inspections |
| Lupin Limited (Biotech Division) | LUBT004 | BLA 761212 | 1 | Nov 14, 2024 | Facility inspections |
| Azurity Pharmaceuticals, Inc. | sitagliptin | NDA 219122 | 3 | Nov 4, 2024 May 28, 2021 Jan 28, 2021 | Facility inspections |
| CSL Behring LLC | CSL312 | BLA 761367 | 1 | Oct 7, 2024 | Facility inspections |
| Scienture Inc. | losartan potassium | NDA 218772 | 1 | Aug 19, 2024 | |
| Antares Pharma, Inc. | hydrocortisone sodium phosphate | NDA 218026 | 2 | Aug 16, 2024 Oct 20, 2017 | |
| Lykos Therapeutics | — | NDA 215455 | 1 | Aug 8, 2024 | Facility inspections |
| RB Health (US) LLC | naproxen sodium | NDA 217338 | 1 | Jul 26, 2024 | |
| Orexo AB | Naloxone hydrochloride | NDA 217433 | 1 | Jul 15, 2024 | |
| MEDRx USA, Inc. | — | NDA 215029 | 1 | Jul 11, 2024 | |
| Novo Nordisk | NNC0148-0287 | BLA 761326 | 2 | Jul 10, 2024 Apr 24, 2023 | Facility inspections |
| Samsung Bioepis Co., Ltd. | Pyzchiva | BLA 761373 | 2 | Jul 4, 2024 Mar 23, 2018 | |
| Daiichi Sankyo, Inc. | — | BLA 761366 | 2 | Jun 26, 2024 Aug 24, 2018 | Facility inspections |
| Nanocopoeia, LLC | — | NDA 217379 | 1 | Jun 14, 2024 | Facility inspections |
| Rocket Pharmaceuticals, Inc. | marnetegragene autotemcel manufactured | 1 | Jun 14, 2024 | ||
| Bayer HealthCare LLC | Naproxen sodium | NDA 218506 | 1 | Jun 13, 2024 | Facility inspections |
| XTM Consulting LLC | — | NDA 218698 | 1 | Jun 12, 2024 | |
| Xbrane Biopharma AB | — | BLA 761187 | 1 | Apr 19, 2024 | Facility inspections |
| Abeona Therapeutics, Inc. | — | 1 | Apr 16, 2024 | ||
| Gan & Lee Pharmaceuticals | — | BLA 761356 | 2 | Apr 12, 2024 Mar 26, 2024 | Facility inspections |
| Baxter Healthcare Corporation | DAPZURA RT | NDA 218224 | 3 | Mar 29, 2024 Mar 27, 2024 Apr 29, 2021 | |
| Fidelity BioPharma Co. | Ontralfy | NDA 216190 | 1 | Mar 29, 2024 | |
| Mapi Pharma Ltd. | glatiramer acetate epi | NDA 218223 | 1 | Mar 8, 2024 | Facility inspections |
| Minerva Neurosciences, Inc | roluperidone | NDA 217002 | 1 | Feb 26, 2024 | |
| Venatorx Pharmaceuticals, Inc. | — | NDA 217556 | 1 | Feb 22, 2024 | |
| Xeris Pharmaceuticals, Inc. | Gvoke | NDA 212097 | 1 | Feb 9, 2024 | |
| AFT Pharmaceuticals Ltd. | sirolimus | NDA 218528 | 4 | Jan 25, 2024 Jun 30, 2022 Nov 6, 2020 Dec 22, 2017 | Facility inspections |
| Defender Pharmaceuticals, Inc | scopolamine | NDA 214315 | 1 | Jan 25, 2024 | |
| Akeso Biopharma Co., Ltd. | AK105 | BLA 761258 | 1 | Jan 19, 2024 | Facility inspections |
| BendaRx USA Corporation | bendamustine | NDA 215291 | 1 | Jan 17, 2024 | |
| SQ Innovation, Inc. | furosemide | NDA 217294 | 1 | Jan 12, 2024 | |
| CooperSurgical, Inc. | Paragard | NDA 018680 | 1 | Dec 18, 2023 | Facility inspections |
| Checkpoint Therapeutics, Incorporated | cosibelimab | BLA 761297 | 1 | Dec 15, 2023 | Facility inspections |
| Galderma R&D, LLC | — | BLA 761311 | 1 | Sep 29, 2023 | |
| Eli Lilly and Company | lebrikizumab | BLA 761306 | 5 | Sep 28, 2023 Mar 30, 2023 Jan 18, 2023 Dec 17, 2021 Dec 17, 2021 | Facility inspections |
| Botanix SB Inc. | sofpironium bromide | NDA 217347 | 1 | Sep 22, 2023 | |
| ARS Pharmaceuticals, Inc. | Neffy | NDA 214697 | 1 | Sep 19, 2023 | |
| Mesoblast, Inc. | — | 1 | Aug 1, 2023 | Facility inspections | |
| Shilpa Medicare Limited | bortezomib | NDA 212782 | 4 | Aug 1, 2023 Apr 14, 2022 Jun 24, 2021 Mar 10, 2020 | Facility inspections |
| Citius Pharmaceuticals, Inc. | Lymphir | BLA 761312 | 1 | Jul 28, 2023 | |
| Laboratorios Farmacéuticos ROVI, S.A. | Risvan | NDA 214835 | 3 | Jul 27, 2023 Jul 15, 2022 Sep 24, 2021 | Facility inspections |
| Impax Laboratories, LLC | Crexont Extended Release | NDA 217186 | 1 | Jun 30, 2023 | |
| AOP Orphan Pharmaceuticals GmbH | landiolol | NDA 217202 | 1 | May 31, 2023 | |
| Galephar Pharmaceutical Research Inc. | Legubeti | NDA 215040 | 1 | May 5, 2023 | |
| Ascendis Pharma Bone Diseases A/S | palopegteriparatide | NDA 216490 | 1 | Apr 28, 2023 | |
| Hugel, Inc | letibotulinumtoxinA | BLA 761225 | 2 | Apr 12, 2023 Mar 31, 2022 | Facility inspections |
| Zydus Worldwide DMCC | sitagliptin | NDA 211566 | 2 | Mar 3, 2023 Sep 2, 2021 | Facility inspections |
| Phathom Pharmaceuticals, Inc. | Voquezna | NDA 215151 | 1 | Feb 7, 2023 | |
| StemCyte, Inc. | Hematopoietic Progenitor Cells | 1 | Jan 20, 2023 | ||
| Almatica Pharma, LLC | zolpidem tartrate | NDA 215721 | 1 | Jan 13, 2023 | |
| Mylan Pharmaceuticals Inc., a Viatris Company | — | NDA 204311 | 1 | Jan 13, 2023 | |
| Liqmeds Worldwide Limited | mycophenolate mofetil | NDA 216482 | 1 | Jan 6, 2023 | |
| lpsen Biopharmaceuticals Inc. | palovarotene | NDA 215559 | 1 | Dec 23, 2022 | |
| Celitrion, Inc. | CT-P17 | BLA 761219 | 2 | Nov 23, 2022 Nov 24, 2021 | Facility inspections |
| Spes Pharmaceuticals Inc. | fosaprepitant | NDA 216686 | 1 | Oct 19, 2022 | |
| CorMedix Inc. | taurolidine | NDA 214520 | 2 | Aug 4, 2022 Feb 26, 2021 | Facility inspections |
| Acer Therapeutics Inc. | sodium phenylbutyrate | NDA 214860 | 1 | Jun 15, 2022 | Facility inspections |
| Braintree Laboratories, Inc. | Suflave | NDA 215344 | 2 | Jun 6, 2022 Mar 13, 2020 | Facility inspections |
| Verrica Pharmaceuticals Inc. | cantharidin | NDA 212905 | 3 | May 23, 2022 Sep 16, 2021 Jul 13, 2020 | |
| UGB, Inc. | UCB4940 | BLA 761151 | 1 | May 12, 2022 | Facility inspections |
| Coherus BioSciences, Inc. | toripalimab-tpzi | BLA 761240 | 2 | Apr 29, 2022 Jun 9, 2017 | Facility inspections |
| CMP Development LLC | sildenafil | NDA 214952 | 4 | Apr 28, 2022 Apr 22, 2021 Feb 23, 2021 Oct 16, 2020 | Facility inspections |
| Teva Neuroscience, Inc. | risperidone | NDA 213586 | 1 | Apr 15, 2022 | |
| Akebia Therapeutics, Inc. | vadadustat | NDA 215192 | 1 | Mar 29, 2022 | |
| Gilead Sciences, Inc. | lenacapavir | NDA 215973 | 2 | Feb 28, 2022 Feb 28, 2022 | |
| Amryt Pharmaceuticals DAC | Filsuvez | NDA 215064 | 1 | Feb 26, 2022 | |
| Green Cross Corporation | immune globulin | 1 | Feb 25, 2022 | ||
| Mallinckrodt Pharmaceuticals Ireland Ltd | terlipressin | NDA 022231 | 1 | Feb 18, 2022 | |
| Shandong Luye Pharmaceutical Co., Ltd. | Rykindo | NDA 212849 | 2 | Feb 18, 2022 Jan 28, 2020 | |
| Pfizer Ireland Pharmaceuticals | MOD-4023 | BLA 761184 | 1 | Jan 21, 2022 | Facility inspections |
| Therakind Limited | Jylamvo | NDA 212479 | 1 | Dec 22, 2021 | Facility inspections |
| Takeda Pharmaceuticals U.S.A., Inc. | Eohilia | NDA 213976 | 2 | Dec 17, 2021 Dec 17, 2019 | |
| Braeburn Inc. | BRIXADI | NDA 210136 | 2 | Dec 15, 2021 Dec 1, 2020 | Facility inspections |
| Fennec Pharmaceuticals, Inc. | PEDMARK | NDA 212937 | 2 | Nov 26, 2021 Aug 10, 2020 | Facility inspections |
| Bio-Thera Solutions Ltd. | BAT1706 | BLA 761198 | 1 | Nov 19, 2021 | Facility inspections |
| Santen, Inc. | Omlonti | NDA 215092 | 1 | Nov 9, 2021 | Facility inspections |
| Eyenovia, Inc. | MYDCOMBI | NDA 215352 | 1 | Oct 22, 2021 | |
| Marius Pharmaceuticals, LLC | testosterone undecanoate | NDA 213953 | 1 | Oct 22, 2021 | Facility inspections |
| Omeros Corporation | OMS721 | BLA 761152 | 1 | Oct 15, 2021 | |
| United Therapeutics Corporation | treprostinil | NDA 214324 | 3 | Oct 15, 2021 Jun 2, 2017 Oct 7, 2016 | |
| Revance Therapeutics, Inc. | daxibotulinumtoxinA | BLA 761127 | 1 | Oct 14, 2021 | |
| Polarean Inc. | Xenoview | NDA 214375 | 1 | Oct 5, 2021 | Facility inspections |
| HQ Specialty Pharma Corporation | Meropenem | NDA 215212 | 4 | Sep 14, 2021 Jan 8, 2021 Dec 26, 2019 Oct 19, 2018 | |
| Zhejiang Novus Pharmaceuticals Co. Ltd. | Vancomycin Hydrochloride | NDA 210274 | 3 | Aug 25, 2021 Nov 27, 2020 Jun 15, 2018 | Facility inspections |
| CellTrans Inc. | Donislecel manufactured at your Chicago | 1 | Aug 18, 2021 | ||
| Kashiv BioSciences, LLC | TPI-120 | BLA 761084 | 4 | Aug 11, 2021 Aug 2, 2021 Dec 22, 2020 Jun 11, 2019 | Facility inspections |
| Spectrum Pharmaceuticals, Inc. | SPI-2012 | BLA 761148 | 1 | Aug 3, 2021 | |
| medac Gesellschaft fur klinische Spezialpraparate mbH | Grafapex | NDA 214759 | 1 | Jul 30, 2021 | |
| Ardelyx, Inc. | tenapanor hydrochloride | NDA 213931 | 1 | Jul 28, 2021 | |
| lterum Therapeutics U.S. Ltd. | sulopenem etzadroxil | NDA 213972 | 1 | Jul 23, 2021 | |
| Provention Bio, Inc. | PRV-031 | BLA 761183 | 1 | Jul 2, 2021 | Facility inspections |
| Cyclomedica Australia Pty Ltd. | Technegas™ Technetium Tc-99m carbon aerosol | NDA 022335 | 1 | Jun 25, 2021 | |
| MediWound, Ltd. | “concentrate of proteolytic enzymes enriched | BLA 761192 | 1 | Jun 25, 2021 | Facility inspections |
| Orphazyme A/S | arimoclomol | NDA 214927 | 1 | Jun 17, 2021 | |
| Nevakar, Inc. | Norepinephrine Bitartrate | NDA 214628 | 1 | Jun 14, 2021 | |
| Chiesi USA, Inc. | PRX-102 | BLA 761161 | 2 | Apr 27, 2021 Jun 19, 2019 | Facility inspections |
| LEO Pharma A/S | tralokinumab | BLA 761180 | 1 | Apr 23, 2021 | |
| PharmaEssentia Corporation | P1101 | BLA 761166 | 1 | Mar 12, 2021 | Facility inspections |
| Novitium Pharma LLC | Hydroxychloroquine Sulfate | NDA 214581 | 1 | Feb 12, 2021 | |
| Emory Partners, LLC | Dyanavel XR | NDA 210526 | 1 | Jan 21, 2021 | |
| InnoPharma Licensing LLC | Acetaminophen | NDA 206968 | 3 | Dec 22, 2020 Nov 9, 2018 Nov 15, 2016 | |
| Novartis Pharmaceuticals Corporation | inclisiran | NDA 214012 | 1 | Dec 18, 2020 | Facility inspections |
| scPharmaceuticals Services, Inc | Furoscix™ “ | NDA 209988 | 1 | Dec 3, 2020 | Facility inspections |
| Genentech, Incorporated | XOFLUZA | NDA 214410 | 1 | Nov 23, 2020 | |
| Adamis Pharmaceuticals Corporation | Naloxone HCI | NDA 212854 | 2 | Nov 13, 2020 Nov 22, 2019 | |
| Alkermes, Inc. | Lybalvi | NDA 213378 | 1 | Nov 13, 2020 | |
| Bioverativ USA, Inc. | sutimlimab | BLA 761164 | 1 | Nov 13, 2020 | Facility inspections |
| sanofi-aventis U.S. LLC | Fexinidazole | NDA 214429 | 1 | Nov 12, 2020 | |
| Supernus Pharmaceuticals, Inc. | viloxazine hydrochloride | NDA 211964 | 1 | Nov 6, 2020 | Facility inspections |
| Mallinckrodt Hospital Products IP Limited | Terlivaz | NDA 022231 | 1 | Sep 11, 2020 | |
| Nobelpharma Co., Ltd. | sirolimus | NDA 213478 | 1 | Aug 13, 2020 | Facility inspections |
| DBV Technologies S.A. | — | 1 | Aug 3, 2020 | ||
| Corium, Inc. | ADLARITY | NDA 212304 | 1 | Jul 23, 2020 | |
| Heron Therapeutics, Inc. | Zynrelef | NDA 211988 | 2 | Jun 26, 2020 Apr 30, 2019 | Facility inspections |
| Esteve Pharmaceuticals, S.A. | celecoxib | NDA 213426 | 1 | Jun 15, 2020 | Facility inspections |
| Althera Life Sciences, LLC | rosuvastatin | NDA 213072 | 1 | May 26, 2020 | |
| Par Sterile Products, LLC | Micafungin | NDA 212156 | 1 | May 18, 2020 | Facility inspections |
| B. Braun Medical, Inc. | Acetaminophen | NDA 204957 | 3 | Apr 24, 2020 Mar 27, 2019 Sep 28, 2017 | Facility inspections |
| IntelGenx Corp. | RizaFilm | NDA 205394 | 2 | Mar 24, 2020 Mar 28, 2019 | Facility inspections |
| Xellia Pharmaceuticals, ApS | Vancomycin | NDA 213895 | 1 | Mar 20, 2020 | |
| Recordati Rare Diseases Inc. | Cystadrops | NDA 211302 | 1 | Jan 28, 2020 | Facility inspections |
| Ingenus Pharmaceuticals, LLC | Cyclophosphamide | NDA 212501 | 1 | Jan 14, 2020 | Facility inspections |
| Sarfez Pharmaceuticals Inc. | pd Pe or to section | NDA 213218 | 1 | Jan 10, 2020 | |
| Sedor Pharmaceuticals, LLC | Sesquient | NDA 210864 | 2 | Dec 20, 2019 Mar 22, 2019 | |
| ViiV Healthcare Company | CABENUVA® | NDA 212888 | 2 | Dec 19, 2019 Dec 19, 2019 | Facility inspections |
| CLASS 2 RESUBMISSION | Romidepsin | NDA 208574 | 1 | Nov 4, 2019 | |
| Clearside Biomedical, Inc. | XIPERE | NDA 211950 | 1 | Oct 18, 2019 | Facility inspections |
| AuroMedics Pharma LLC | Cyclophosphamide | NDA 210735 | 3 | Oct 1, 2019 Jan 15, 2019 Apr 26, 2018 | |
| AstraZeneca AB | Breztri Aerosphere | NDA 212122 | 1 | Sep 30, 2019 | |
| Mylan GmbH | insulin glargine | NDA 210605 | 2 | Aug 28, 2019 May 17, 2018 | Facility inspections |
| Sarepta Therapeutics, Inc. | Vyondys | NDA 211970 | 1 | Aug 19, 2019 | |
| Bioprojet Pharma | Wakix | NDA 211150 | 1 | Aug 14, 2019 | |
| Kala Pharmaceuticals, Inc. | Eysuvis | NDA 210933 | 1 | Aug 7, 2019 | |
| Mylan Pharmaceuticals Inc. | — | NDA 204311 | 3 | Aug 6, 2019 Feb 27, 2015 Oct 23, 2014 | Facility inspections |
| Bausch Health Ireland Limited | fluorescein sodium | NDA 211039 | 1 | Jul 19, 2019 | |
| Ricon Pharma, LLC | Cyclophosphamide | NDA 212501 | 1 | Jul 18, 2019 | Facility inspections |
| Glenmark Pharmaceuticals, Inc. | GSP | NDA 211746 | 1 | Jun 20, 2019 | |
| Mylan Laboratories Limited | Acetaminophen © | NDA 206610 | 4 | Jun 6, 2019 Dec 6, 2017 Feb 1, 2017 Mar 10, 2016 | |
| Acacia Pharma Ltd | Barhemsys | NDA 209510 | 2 | May 2, 2019 Oct 5, 2018 | Facility inspections |
| Evoke Pharma, Inc. | Gimoti | NDA 209388 | 1 | Apr 1, 2019 | |
| Proximagen, LLC | Nayzilam | NDA 211321 | 1 | Mar 29, 2019 | |
| Fera Pharmaceuticals, LLC | Avaclyr | NDA 202408 | 3 | Mar 28, 2019 Jun 24, 2016 Mar 31, 2014 | |
| Recro Pharma Inc. | Meloxicam | NDA 210583 | 2 | Mar 22, 2019 May 23, 2018 | |
| Sunovion Pharmaceuticals Inc. | Kynmobi | NDA 210875 | 1 | Jan 29, 2019 | |
| Vero Biotech, LLC | GENOsyl® © Delivery | NDA 202860 | 1 | Jan 23, 2019 | |
| Immunomedics, Inc | sacituzumab govitecan | BLA 761115 | 1 | Jan 17, 2019 | Facility inspections |
| Braeburn Pharmaceuticals Inc. | BRIXADI | NDA 210136 | 2 | Dec 21, 2018 Jan 19, 2018 | |
| International Medication Systems, Limited | Epinephrine | NDA 211363 | 1 | Dec 12, 2018 | |
| Innocoll Pharmaceuticals | bupivacaine hydrochloride collagen-matrix implants | NDA 209511 | 1 | Nov 30, 2018 | |
| Valeant Pharmaceuticals Ireland | tetracaine hydrochloride | NDA 210821 | 1 | Nov 20, 2018 | Facility inspections |
| Trevena, Inc. | Oliceridine | NDA 210730 | 1 | Nov 2, 2018 | |
| AB Pharmaceuticals, LLC | — | NDA 210649 | 2 | Sep 12, 2018 Mar 13, 2018 | |
| Lannett Holdings, Inc. | Cocaine Hydrochloride | NDA 209575 | 1 | Jul 20, 2018 | |
| Actavis LLC, an indirect, wholly-owned subsidiary of Teva Pharmaceuticals U.S.A. Inc. | Pemetrexed | NDA 208419 | 1 | Jun 26, 2018 | |
| Metacel Pharmaceuticals, LLC | Ozobax | NDA 208193 | 2 | Jun 25, 2018 Jan 11, 2017 | |
| Dow Pharmaceutical Sciences, Inc. | halobetasol propionate | NDA 209354 | 1 | Jun 15, 2018 | |
| scPharmaceuticals, Inc. | Furoscix™ Furosemide | NDA 209988 | 1 | Jun 11, 2018 | |
| Amgen Inc. | Kanjinti | BLA 761073 | 3 | May 25, 2018 Jul 13, 2017 Aug 27, 2015 | |
| Evolus, Inc. | otulinum toxin Type A | BLA 761085 | 1 | May 15, 2018 | Facility inspections |
| Adello Biologics, LLC | — | BLA 761082 | 1 | May 10, 2018 | Facility inspections |
| Pfizer Inc. | Trazimera | BLA 761081 | 1 | Apr 20, 2018 | Facility inspections |
| Clarus Therapeutics, Inc. | testosterone undecanoate | NDA 206089 | 2 | Mar 22, 2018 Nov 3, 2014 | |
| Agile Therapeutics, Inc. | levonorgestrel/ethinyl estradiol | NDA 204017 | 3 | Dec 21, 2017 Jul 17, 2013 Feb 13, 2013 | Facility inspections |
| Teva Pharmaceuticals USA | Fulvestrant | NDA 210063 | 4 | Oct 26, 2017 Jun 2, 2017 Sep 30, 2016 Jun 1, 2016 | Facility inspections |
| AcelRx Pharmaceuticals, Inc. | DSUVIA | NDA 209128 | 1 | Oct 11, 2017 | |
| Actavis, L.L.C. | Pemetrexed Injection | NDA 208419 | 1 | Sep 26, 2017 | Facility inspections |
| 3M Health Care (Infection Prevention Division) | SoluPrep™ | NDA 208288 | 2 | Sep 1, 2017 May 6, 2016 | |
| Ironshore Pharmaceuticals & Development, Inc. | Jornay PM Modified Release | NDA 209311 | 1 | Jul 28, 2017 | |
| Ocular Therapeutix, Inc. | DEXTENZA | NDA 208742 | 2 | Jul 10, 2017 Jul 21, 2016 | Facility inspections |
| TherapeuticsMD, Inc. | estradiol | NDA 208564 | 1 | May 5, 2017 | |
| Institut Biochimique SA (IBSA) | diclofenac epolamine | NDA 206976 | 1 | Mar 24, 2017 | |
| Sun Pharma Advanced Research Company Limited | Elepsia XR | NDA 204417 | 5 | Mar 22, 2017 Dec 19, 2016 Sep 23, 2015 Jul 30, 2015 Nov 24, 2014 | |
| Armstrong Pharmaceuticals | Primatene Mist | NDA 205920 | 2 | Dec 23, 2016 May 22, 2014 | Facility inspections |
| The Feinstein Institute for Medical Research | Fluorodopa F | NDA 200655 | 1 | Sep 15, 2016 | |
| Salamandra, LLC | rosuvastatin | NDA 208647 | 1 | Jun 22, 2016 | |
| Scilex Pharmaceuticals, Inc. | ZTlido | NDA 207962 | 1 | May 10, 2016 | Facility inspections |
| Evofem, Inc. | Amphora | NDA 208352 | 1 | Apr 28, 2016 | |
| Camargo Pharmaceutical Services | Mycapssa | NDA 208232 | 1 | Apr 15, 2016 | |
| Belcher Pharmaceuticals, LLC. | Ablysinol | NDA 207987 | 1 | Dec 9, 2015 | |
| ELC Group | Lutrate® | NDA 205054 | 1 | May 29, 2015 | |
| nnoPharma Licensing LLC | Acetaminophen njection | NDA 206968 | 1 | Feb 27, 2015 | |
| DURECT Corporation | POSIMIR | NDA 204803 | 1 | Feb 12, 2014 | |
| RedHill Biopharma Ltd. | Rizaport | NDA 205394 | 1 | Jan 31, 2014 | |
| NorthStar Medical Radioisotopes, LLC | TechneGen Generator | NDA 202158 | 1 | Nov 4, 2013 | |
| Thomas Chaly, Ph.D., FAIC | Fluorodopa F | NDA 200655 | 1 | Oct 22, 2013 | |
| Delcath Systems, Incorporated | Melblez | NDA 201848 | 1 | Sep 12, 2013 | |
| GeNO LLC | GENOsyl™ ©® | NDA 202860 | 2 | Jun 28, 2013 May 18, 2012 | Facility inspections |
| Merck & Co., Inc. | Suvorexant | NDA 204569 | 1 | Jun 28, 2013 | |
| AVEO Pharmaceuticals, Inc. | tivozanib hydrochloride | NDA 204408 | 1 | Jun 6, 2013 | |
| Roxane Laboratories, Inc. | Cyclophosphamide | NDA 203856 | 1 | May 3, 2013 | |
| Sun Pharma Global FZE | Levetiracetam | NDA 204417 | 1 | Mar 29, 2013 | |
| Pharmaxis Ltd. | Bronchitol | NDA 202049 | 1 | Mar 18, 2013 | |
| Otsuka Pharmaceutical Company, Ltd. | ABILIFY MAINTENA | NDA 202971 | 1 | Jul 26, 2012 | |
| Chelsea Therapeutics, Inc. | NORTHERA | NDA 203202 | 1 | Mar 28, 2012 | |
| Bristol-Myers Squibb | dapagliflozin | NDA 202293 | 1 | Jan 17, 2012 | |
| EMD Serono, Inc. | cladribine | NDA 022561 | 1 | Feb 28, 2011 | |
| Teva Women’s Health, Inc. | progesterone | NDA 201110 | 1 | Feb 28, 2011 | |
| Cadence Pharmaceuticals | Ofirmev | NDA 022450 | 1 | Feb 10, 2010 | Facility inspections |
| Orphan Therapeutics, LLC | Lucassin | NDA 022231 | 1 | Nov 4, 2009 | |
| King Pharmaceuticals, Inc. | sumatriptan | NDA 022377 | 1 | May 15, 2009 | |
| Kyowa Pharmaceutical, Inc. | istradefylline | NDA 022075 | 1 | Feb 25, 2008 | |
| Fabre-Kramer Pharmaceuticals, Inc. | Gepirone Hydrochloride Extended Release | NDA 021164 | 1 | Nov 2, 2007 | |
| Organon, Inc. | Gepirone hydrochloride | NDA 021164 | 2 | Jun 23, 2004 Mar 15, 2002 |
Concepts
- Facility inspections in FDA Complete Response Letters
126 companies · Where a Complete Response Letter, or the company's own filing, points to an inspection of a manufacturing facility.
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.