Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088128
Company: WATSON LABS
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 | 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 |
|---|---|---|---|---|---|---|---|
| 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. |
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| 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. |
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| 12/08/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1996 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 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. |
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| 02/11/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 11/21/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/04/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 12/13/1988 | SUPPL-6 | Bioequivalence |
Label is not available on this site. |
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| 12/05/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/05/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/07/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |