Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | AB | No | No |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/13/1986 | 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 |
|---|---|---|---|---|---|
| 05/18/2015 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/14/2008 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 05/03/2005 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 06/27/2002 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 04/25/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/28/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 09/08/1998 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 02/18/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 06/21/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 03/21/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1990 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 05/08/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 06/03/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/03/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/22/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/22/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
PROPRANOLOL HYDROCHLORIDE
TABLET;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 070221 | ENDO OPERATIONS |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 071976 | IMPAX LABS INC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 070322 | INNOGENIX |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 078955 | IPCA LABS LTD |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 070213 | MYLAN |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 078213 | NORTHSTAR HLTHCARE |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 070178 | WATSON LABS |