Complete Response Letters
Mallinckrodt Pharmaceuticals Ireland Ltd: terlipressin
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Feb 18, 2022
Cosmetic Act (FDCA) for terlipressin injection.
CRL_NDA022231_20220218:p1:s12We acknowledge receipt of your draft labeling received on February 15, 2022. We reserve further comment on the proposed labeling until the application is otherwise adequate.
CRL_NDA022231_20220218:p1:s22We acknowledge receipt of your draft Carton and Container labeling on February 15, 2022.
CRL_NDA022231_20220218:p1:s32We reserve further comment on the proposed labeling until the application is otherwise adequate.
CRL_NDA022231_20220218:p1:s33This name was found to be acceptable pending approval of the application in the current review cycle.
CRL_NDA022231_20220218:p1:s36Between the FDA and Sponsors or Applicants of PDUFA Products.
CRL_NDA022231_20220218:p2:s19More Complete Response Letters
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