Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210917
Company: INGENUS PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 10MG BASE/ML 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
11/23/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

LEUCOVORIN CALCIUM

INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 207226 FRESENIUS KABI USA
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 210917 INGENUS PHARMS LLC
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 040347 WEST-WARD PHARMS INT

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