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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081235
Company: MYLAN

Products on ANDA 081235

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 081235

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
05/27/2026	SUPPL-36	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/04/2021	SUPPL-30	Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 081235

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	081099	BARR
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

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