Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078652
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | 2.5MG; 10MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | 5MG; 10MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | 5MG; 20MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | 10MG; 20MG | CAPSULE; ORAL | None (Tentative Approval) | 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 |
---|---|---|---|---|---|---|---|
03/28/2013 | ORIG-1 | Tentative Approval |
Label is not available on this site. |