Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081235
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
01/03/2019 SUPPL-29 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/04/2014 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

05/11/2004 SUPPL-13 Labeling

Label is not available on this site.

02/20/2004 SUPPL-12 Labeling

Label is not available on this site.

03/13/2002 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

06/20/2000 SUPPL-9 Labeling

Label is not available on this site.

08/31/1998 SUPPL-8 Labeling

Label is not available on this site.

06/09/1998 SUPPL-7 Labeling

Label is not available on this site.

02/05/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/18/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/29/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/04/1994 SUPPL-2 Labeling

Label is not available on this site.

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 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 Yes AB 008085 DAVA PHARMS INC
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

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