Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077375
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE;ORAL | Discontinued | None | No | No |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE;ORAL | Discontinued | None | No | No |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE;ORAL | Discontinued | None | No | No |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
05/21/2010 | 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 |
---|---|---|---|---|---|
08/16/2021 | SUPPL-14 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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08/16/2021 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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02/21/2020 | SUPPL-11 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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01/04/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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01/04/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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01/04/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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11/04/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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12/31/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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10/21/2011 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |