Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086385
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NANDROLONE DECANOATE NANDROLONE DECANOATE 50MG/ML INJECTABLE;INJECTION Discontinued None No 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
01/13/1984 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/19/1999 SUPPL-28 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-27 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/08/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/04/1996 SUPPL-25 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/29/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/04/1993 SUPPL-23 Labeling

Label is not available on this site.

02/11/1991 SUPPL-22 Labeling

Label is not available on this site.

11/21/1989 SUPPL-21 Labeling

Label is not available on this site.

06/21/1989 SUPPL-17 Labeling

Label is not available on this site.

02/01/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/01/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/01/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/08/1988 SUPPL-12 Labeling

Label is not available on this site.

05/02/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/07/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/08/1989 SUPPL-7 Bioequivalence

Label is not available on this site.

01/13/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/17/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/30/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/30/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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