Complete Response Letters

Mylan Laboratories Limited: Acetaminophen ©

What FDA's Complete Response Letters to the company say, in the letters' own words.

EphemerisX Research · Sep 30, 2026 · Sources: FDA, SEC

Complete Response Letter, Jun 6, 2019

January 24, 2017, paragraph IV certification for NDA 022450 for Ofirmev (acetaminophen).

Complete Response Letter · Jun 6, 2019 · p. 3Open the letter at p. 3 ↗CRL_NDA206610_20190606:p1:s27

Please refer to your New Drug Application (NDA) dated May 3, 2014, received May 5, 2014, and your amendments, submitted.

Complete Response Letter · Dec 6, 2017 · p. 7Open the letter at p. 7 ↗CRL_NDA206610_20171206:p1:s13

We acknowledge receipt of your submission dated June 7, 2017, which constituted a complete response to our February 1, 2017, action letter.

Complete Response Letter · Dec 6, 2017 · p. 7Open the letter at p. 7 ↗CRL_NDA206610_20171206:p1:s16

Cosmetic Act for Acetaminophen ©® for Injection, 1 g/vial.

Complete Response Letter · Feb 1, 2017 · p. 2Open the letter at p. 2 ↗CRL_NDA206610_20170201:p1:s13

Between the FDA and Sponsors or Applicants of PDUFA Products," March 2015 at http://www.

Complete Response Letter · Feb 1, 2017 · p. 9Open the letter at p. 9 ↗CRL_NDA206610_20170201:p2:s32

Mylan Laboratories Limited c/o Mylan Pharmaceuticals Inc.

Complete Response Letter · Mar 10, 2016 · p. 2Open the letter at p. 2 ↗CRL_NDA206610_20160310:p1:s6

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