Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209110
Company: SAGENT PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 500MG 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
10/26/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

LEUCOVORIN CALCIUM PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 500MG 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 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040286 FRESENIUS KABI USA
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 209110 SAGENT PHARMS INC

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