Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011719
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOTREXATE LPF METHOTREXATE SODIUM EQ 25MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Discontinued None No No
METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE;INJECTION Discontinued None No No
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 20MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 25MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 100MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/10/1959 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2021 SUPPL-131 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011719Orig1s131lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/011719Orig1s131ltr.pdf
03/15/2018 SUPPL-126 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011719s126lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011719Orig1s126ltr.pdf
05/07/2018 SUPPL-125 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011719s125lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011719Orig1s125ltr.pdf
02/03/2016 SUPPL-124 Manufacturing (CMC)

Label is not available on this site.

11/20/2015 SUPPL-122 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011719s122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011719Orig1s122ltr.pdf
08/14/2015 SUPPL-121 Manufacturing (CMC)

Label is not available on this site.

11/01/2011 SUPPL-117 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011719s117lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011719s117ltr.pdf
04/13/2005 SUPPL-108 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011719s108ltr.pdf
12/15/2004 SUPPL-107 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719s107ltr.pdf
01/27/2004 SUPPL-106 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11719slr106_methotrexate_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719slr106ltr.pdf
07/29/2003 SUPPL-105 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11719slr105ltr.pdf
01/03/2003 SUPPL-104 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11719slr104ltr.pdf
02/20/2002 SUPPL-103 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf
02/20/2002 SUPPL-102 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf
05/08/2001 SUPPL-100 Labeling

Label is not available on this site.

10/29/1999 SUPPL-99 Labeling

Label is not available on this site.

02/12/1999 SUPPL-98 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/1998 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

11/08/2000 SUPPL-96 Labeling

Label is not available on this site.

05/20/1997 SUPPL-95 Labeling

Label is not available on this site.

04/25/1995 SUPPL-94 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1992 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

11/05/1991 SUPPL-86 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/24/1990 SUPPL-85 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/1991 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1989 SUPPL-81 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1988 SUPPL-79 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/07/1988 SUPPL-78 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1988 SUPPL-77 Efficacy-New Indication

Label is not available on this site.

01/18/1990 SUPPL-76 Labeling

Label is not available on this site.

12/08/1986 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

08/18/1987 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

09/16/1986 SUPPL-73 Labeling

Label is not available on this site.

09/16/1986 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

03/19/1987 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

04/08/1983 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1982 SUPPL-62 Labeling

Label is not available on this site.

04/08/1983 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

03/31/1982 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1982 SUPPL-57 Labeling

Label is not available on this site.

12/07/1981 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

05/11/1981 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

12/03/1980 SUPPL-53 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/29/1980 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1979 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

06/11/1980 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

02/15/1979 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1978 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1978 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

01/02/1979 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1978 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1977 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/18/1977 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/1977 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/02/1977 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/14/1976 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1976 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1976 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1976 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/07/1976 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1976 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1976 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/29/1976 SUPPL-26 Labeling

Label is not available on this site.

06/29/1976 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/05/1975 SUPPL-24 Labeling

Label is not available on this site.

11/03/1975 SUPPL-23 Labeling

Label is not available on this site.

11/03/1975 SUPPL-22 Labeling

Label is not available on this site.

07/22/1975 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/29/2021 SUPPL-131 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011719Orig1s131lbl.pdf
05/07/2018 SUPPL-125 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011719s125lbl.pdf
03/15/2018 SUPPL-126 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011719s126lbl.pdf
11/20/2015 SUPPL-122 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011719s122lbl.pdf
11/20/2015 SUPPL-122 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011719s122lbl.pdf
11/01/2011 SUPPL-117 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011719s117lbl.pdf
01/27/2004 SUPPL-106 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11719slr106_methotrexate_lbl.pdf

METHOTREXATE LPF

There are no Therapeutic Equivalents.

METHOTREXATE PRESERVATIVE FREE

There are no Therapeutic Equivalents.

METHOTREXATE SODIUM

INJECTABLE;INJECTION; EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040263 FRESENIUS KABI USA
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription Yes AP 011719 HOSPIRA
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040767 ACCORD HLTHCARE
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040843 PHARMACHEMIE BV
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 203407 SAGENT PHARMS INC
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 090039 SANDOZ INC
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 089340 WEST-WARD PHARMS INT

METHOTREXATE SODIUM PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040716 ACCORD HLTHCARE
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription Yes AP 011719 HOSPIRA
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 201530 MYLAN LABS LTD
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040843 PHARMACHEMIE BV
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 203407 SAGENT PHARMS INC
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 090029 SANDOZ INC

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