Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079135
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
| TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
| TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | Yes |
| TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 08/30/2010 | ORIG-3 | Approval |
Label is not available on this site. |
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| 05/26/2010 | ORIG-2 | Approval |
Label is not available on this site. |
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| 05/05/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079135s003ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/14/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/14/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/14/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/14/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/01/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/01/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/01/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |