Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078477
Company: AMNEAL PHARMS NY
Company: AMNEAL PHARMS NY
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 |
---|---|---|---|---|---|---|---|
01/16/2008 | 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 |
---|---|---|---|---|---|
04/05/2018 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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11/24/2015 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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09/26/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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07/26/2011 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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11/01/2011 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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05/27/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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11/01/2011 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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11/01/2011 | SUPPL-5 | Labeling |
Label is not available on this site. |