Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088358
Company: IVAX PHARMS
Company: IVAX PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 100MG;50MG | 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 |
---|---|---|---|---|---|---|---|
04/10/1984 | ORIG-1 | Approval |
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