Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208775
Company: CIPLA LIMITED
Company: CIPLA LIMITED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ABACAVIR AND LAMIVUDINE | ABACAVIR; LAMIVUDINE | 120MG;60MG | TABLET, FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
04/06/2017 | ORIG-1 | Tentative Approval | Type 3 - New Dosage Form | STANDARD |
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