Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210133
Company: PRINSTON PHARMA INC
Company: PRINSTON PHARMA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
APIXABAN | APIXABAN | 2.5mg | TABLET; ORAL | None (Tentative Approval) | None | No | No |
APIXABAN | APIXABAN | 5mg | TABLET; 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 |
---|---|---|---|---|---|---|---|
04/12/2022 | ORIG-1 | Tentative Approval | STANDARD |
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