Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074322
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Discontinued | None | No | No |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| CAPTOPRIL | CAPTOPRIL | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/13/1996 | 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 |
|---|---|---|---|---|---|
| 10/30/2015 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/20/2009 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 04/04/2006 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 01/27/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 07/30/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 06/10/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 06/24/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 08/06/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |