Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206167
Company: TEVA PHARMS USA INC
Company: TEVA PHARMS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRALATREXATE | PRALATREXATE | 20MG/1ML | INJECTABLE;INJECTION | None (Tentative Approval) | None | No | No |
PRALATREXATE | PRALATREXATE | 40MG/2ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
01/21/2016 | ORIG-1 | Tentative Approval | STANDARD |
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