Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201850
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | 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 |
---|---|---|---|---|---|---|---|
01/20/2012 | ORIG-1 | Approval |
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