Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 074737
Company: APOTEX
Company: APOTEX
| 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 |
|---|---|---|---|---|---|---|---|
| 10/28/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74737ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/16/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2011 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
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