Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090718
Company: GLENMARK PHARMS
Company: GLENMARK PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE | 12.5MG;7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE | 12.5MG;15MG | TABLET;ORAL | Discontinued | None | No | No |
| MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE | 25MG;15MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/17/2010 | 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/26/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |