Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040263
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription AP No Yes
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Discontinued None 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
02/26/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40263_Methotrexate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40263ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040263_methotrexate_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/07/2017 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

03/29/2012 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

12/02/2002 SUPPL-1 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
02/26/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40263_Methotrexate_Prntlbl.pdf

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

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