Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040385
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TREXALL | METHOTREXATE SODIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | None | No | No |
| TREXALL | METHOTREXATE SODIUM | EQ 7.5MG BASE | TABLET;ORAL | Prescription | None | No | No |
| TREXALL | METHOTREXATE SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | None | No | No |
| TREXALL | METHOTREXATE SODIUM | EQ 15MG BASE | TABLET;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/21/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40385ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040385_S000_TREXALL TABLETS _ORIGINAL.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/14/2021 | SUPPL-21 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/20/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/09/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/03/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |