Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078083
Company: DASH PHARMS
Company: DASH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLIPIZIDE AND METFORMIN HYDROCHLORIDE | GLIPIZIDE; METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET;ORAL | Discontinued | None | No | No |
| GLIPIZIDE AND METFORMIN HYDROCHLORIDE | GLIPIZIDE; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Discontinued | None | No | No |
| GLIPIZIDE AND METFORMIN HYDROCHLORIDE | GLIPIZIDE; METFORMIN HYDROCHLORIDE | 5MG;500MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/12/2007 | 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 |
|---|---|---|---|---|---|
| 04/05/2017 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/02/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/02/2015 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/17/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |