Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077537
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Discontinued | None | No | No |
| GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| GLYBURIDE | GLYBURIDE | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/18/2007 | 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 |
|---|---|---|---|---|---|
| 10/06/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/31/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English