Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080521
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISONIAZID | ISONIAZID | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/28/1972 | 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 |
|---|---|---|---|---|---|
| 04/03/1998 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1997 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 01/26/1993 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1992 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 11/19/1990 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1991 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1991 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/25/1983 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |