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Abbreviated New Drug Application (ANDA): 040266
Company: FRESENIUS KABI USA
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
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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/14/2021 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient 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.

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

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
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