Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070301
Company: WATSON LABS
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|---|---|
04/18/1986 | 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 |
---|---|---|---|---|---|
04/28/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
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01/31/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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03/21/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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08/02/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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01/13/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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12/24/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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10/10/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |