Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070705
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE | 25MG;80MG | TABLET;ORAL | Discontinued | None | No | No |
| PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE | 25MG;40MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/01/1986 | 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/23/2020 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/21/1999 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 04/13/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 05/20/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/23/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/28/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/18/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/10/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/17/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/17/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |