Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013601
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MUCOMYST ACETYLCYSTEINE 20% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INHALATION, ORAL Discontinued None Yes No
MUCOMYST ACETYLCYSTEINE 10% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INHALATION, ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/14/1963 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2001 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

03/19/1997 SUPPL-52 Labeling

Label is not available on this site.

04/21/1997 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

04/05/1991 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

03/13/2009 SUPPL-49 Labeling

Label is not available on this site.

07/13/1993 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/2009 SUPPL-46 Efficacy-New Route Of Administration

Label is not available on this site.

01/16/1987 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1986 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1983 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-37 Labeling

Label is not available on this site.

11/20/1981 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1985 SUPPL-35 Efficacy

Label is not available on this site.

01/10/1980 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1979 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1979 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1978 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1978 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

09/01/1978 SUPPL-29 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/013601Orig1s029.pdf
02/08/1980 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1977 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/06/1977 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/15/1977 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/02/1975 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1975 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1975 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/19/1974 SUPPL-18

Label is not available on this site.

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