Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203800
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 350MG 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
05/19/2017 ORIG-1 Approval

Label is not available on this site.

LEUCOVORIN CALCIUM PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 100MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 081277 TEVA PHARMS USA
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 089717 WEST-WARD PHARMS INT
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203800 MYLAN LABS LTD
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200753 SAGENT PHARMS

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

INJECTABLE;INJECTION; EQ 350MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040174 TEVA PHARMS USA
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203800 MYLAN LABS LTD
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200855 SAGENT PHARMS
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040335 WEST-WARD PHARMS INT

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