Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201749
Company: SUN PHARM
Company: SUN PHARM
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 |
---|---|---|---|---|---|---|---|
05/21/2015 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/08/2021 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2021 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2021 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert |
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 | 217552 | ALEMBIC |
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 | 216453 | ELITE LABS INC |
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 |