Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077274
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLIMEPIRIDE | GLIMEPIRIDE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| GLIMEPIRIDE | GLIMEPIRIDE | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| GLIMEPIRIDE | GLIMEPIRIDE | 4MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/06/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077274ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/31/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/17/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/01/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/15/2006 | SUPPL-1 | Labeling |
Label is not available on this site. |