Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089322
Company: ABRAXIS PHARM
Company: ABRAXIS PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 25MG BASE/ML | INJECTABLE;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 |
---|---|---|---|---|---|---|---|
06/13/1986 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/18/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
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02/17/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |