Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075727
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET;ORAL | Discontinued | None | No | No |
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/18/2001 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75727TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75727ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/28/2020 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/02/2011 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 07/24/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/27/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |