Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040233
Company: DURAMED PHARMS BARR
Company: DURAMED PHARMS BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
06/17/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40233ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/40233_Methotrexate.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/23/2000 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |