Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070947
Company: RISING
Company: RISING
| 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 |
|---|---|---|---|---|---|---|---|
| 04/01/1987 | 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-35 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/01/2015 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/31/2010 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 10/07/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 08/20/2002 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 10/15/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 09/05/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/02/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/09/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/25/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/06/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/04/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |