Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080713
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIPELENNAMINE HYDROCHLORIDE | TRIPELENNAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/18/1973 | 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 |
|---|---|---|---|---|---|
| 04/14/1999 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 10/15/1990 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1989 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 10/15/1990 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1990 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1986 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1986 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1983 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |