Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074544
Company: EPIC PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 5MG BASE TABLET;ORAL Prescription AB No No
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 25MG BASE TABLET;ORAL Prescription AB 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
08/28/1997 ORIG-1 Approval

Label is not available on this site.

LEUCOVORIN CALCIUM

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 071198 BARR
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 074544 EPIC PHARMA LLC
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 072733 HIKMA
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 211132 RICONPHARMA LLC

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 25MG BASE TABLET;ORAL Prescription No AB 071199 BARR
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 25MG BASE TABLET;ORAL Prescription No AB 074544 EPIC PHARMA LLC
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 25MG BASE TABLET;ORAL Prescription No AB 072736 HIKMA
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 25MG BASE TABLET;ORAL Prescription No AB 211132 RICONPHARMA LLC

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