Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019059
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDERIDE LA 120/50 | HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE | 50MG;120MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| INDERIDE LA 160/50 | HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE | 50MG;160MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| INDERIDE LA 80/50 | HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE | 50MG;80MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 07/03/1985 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/03/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 11/01/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 05/08/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 05/14/1990 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/12/1989 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/10/1989 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/25/1989 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/25/1988 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/06/1987 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 11/12/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/20/1987 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 07/02/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/20/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/20/1986 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 07/24/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1985 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |