Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070551
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/10/1986 | 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 |
|---|---|---|---|---|---|
| 08/31/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/17/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 11/10/1999 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/09/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 06/04/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 02/04/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/10/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 07/24/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 02/28/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 11/29/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/10/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 03/20/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 02/20/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |