Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208260
Company: PHARMTAK INC
Company: PHARMTAK INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | 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 |
---|---|---|---|---|---|---|---|
12/26/2018 | ORIG-1 | Tentative Approval | STANDARD |
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