Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081099
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-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels

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-Package Insert, Labeling-Container/Carton Labels

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 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 209787 LOTUS PHARM CO LTD
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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