Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040258
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 200MG 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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40258ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2011 SUPPL-6 Labeling-Container/Carton Labels

Label is not available on this site.

LEUCOVORIN CALCIUM PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 200MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040258 FRESENIUS KABI USA
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203800 MYLAN LABS LTD
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200753 SAGENT PHARMS
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040056 WEST-WARD PHARMS INT

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