Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040265
Company: FRESENIUS KABI USA

Products on ANDA 040265

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	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040265

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.

Labels for ANDA 040265

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