Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090649
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 06/21/2010 | 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 |
|---|---|---|---|---|---|
| 02/03/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/16/2013 | SUPPL-6 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/29/2012 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/29/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |