Drugs@FDA: FDA-Approved Drugs
Company: 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 | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 10/15/1990 | 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 |
|---|---|---|---|---|---|
| 10/20/2020 | SUPPL-45 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/20/2020 | SUPPL-41 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/20/2020 | SUPPL-39 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/02/2010 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2002 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 08/22/2002 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/10/2000 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 12/20/2000 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/06/1999 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/06/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/06/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/30/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/26/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/10/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
METHOTREXATE SODIUM
TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 213343 | ACCORD HLTHCARE |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 210040 | AMNEAL PHARMS |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 081099 | BARR |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 213362 | DAITO |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 210454 | EUGIA PHARMA |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 040054 | HIKMA |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 081235 | MYLAN |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 201749 | SUN PHARM |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 207812 | ZYDUS PHARMS |