Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088128
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NANDROLONE DECANOATE NANDROLONE DECANOATE 200MG/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
12/05/1983 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
06/17/2002 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/17/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/2002 SUPPL-17 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/19/1999 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/08/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

07/19/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/04/1993 SUPPL-10 Labeling

Label is not available on this site.

02/11/1991 SUPPL-9 Labeling

Label is not available on this site.

11/21/1989 SUPPL-8 Labeling

Label is not available on this site.

08/04/1989 SUPPL-7 Labeling

Label is not available on this site.

12/13/1988 SUPPL-6 Bioequivalence

Label is not available on this site.

12/05/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/05/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/30/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/07/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English