Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072502
Company: INWOOD LABS
Company: INWOOD LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 04/11/1989 | 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 |
|---|---|---|---|---|---|
| 09/30/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/16/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/09/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/26/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/31/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/23/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 05/18/1993 | SUPPL-4 | Bioequivalence |
Label is not available on this site. |
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| 02/22/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |