Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201380
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|---|---|
04/13/2012 | 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 |
---|---|---|---|---|---|
06/07/2023 | SUPPL-17 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
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04/03/2018 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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12/03/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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09/19/2014 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |