Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040266
Company: FRESENIUS KABI USA

Products on ANDA 040266

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHOTREXATE PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040266

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/99/40266_Methotrexate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40266ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040266_methotrexate-preservative-free_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2024	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
09/18/2023	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/14/2021	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/14/2021	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/03/2017	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/28/2012	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/24/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 040266

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/99/40266_Methotrexate_Prntlbl.pdf

Therapeutic Equivalents for ANDA 040266

METHOTREXATE PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
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 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040266	FRESENIUS KABI USA
METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040632	HIKMA