Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071288
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 90MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/22/1986 | 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 |
|---|---|---|---|---|---|
| 01/10/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/13/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 04/23/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 09/06/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 03/04/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/04/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/04/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/04/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/04/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |