Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077262
Company: HIKMA
Company: HIKMA
| 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 |
|---|---|---|---|---|---|---|---|
| 07/09/2007 | 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 |
|---|---|---|---|---|---|
| 04/02/2018 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/25/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/20/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/13/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |