Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040265
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription AP 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/99/40265_Methotrexate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40265ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040265_methotrexate-preservative-free_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/03/2017 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/02/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/2001 SUPPL-5 Labeling

Label is not available on this site.

10/16/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/2001 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/16/2001 SUPPL-2 Manufacturing (CMC)-New Strength

Label is not available on this site.

02/17/2000 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/99/40265_Methotrexate_Prntlbl.pdf

METHOTREXATE PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 25MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription No AP 040265 FRESENIUS KABI USA

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