Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078231
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 11/30/2007 | 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 |
|---|---|---|---|---|---|
| 01/15/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |