Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
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 |
---|---|---|---|---|---|---|---|
05/15/1992 | 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 |
---|---|---|---|---|---|
06/04/2021 | SUPPL-30 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
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01/03/2019 | SUPPL-29 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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04/04/2014 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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05/11/2004 | SUPPL-13 | Labeling |
Label is not available on this site. |
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02/20/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
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03/13/2002 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/13/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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06/20/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
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08/31/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
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06/09/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
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02/05/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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04/18/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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07/29/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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10/04/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
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10/04/1994 | 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 |