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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211132
Company: INGENUS PHARMS 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 10MG BASE TABLET;ORAL Prescription AB No No
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 15MG BASE TABLET;ORAL Prescription AB No No
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 25MG BASE TABLET;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/30/2020 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/05/2026 SUPPL-5 Labeling-Package Insert

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 INGENUS PHARMS LLC
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 213929 LEADING

TABLET;ORAL; EQ 10MG 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 10MG BASE TABLET;ORAL Prescription No AB 074544 EPIC PHARMA LLC
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 072734 HIKMA
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 211132 INGENUS PHARMS LLC
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 213929 LEADING

TABLET;ORAL; EQ 15MG 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 15MG BASE TABLET;ORAL Prescription No AB 074544 EPIC PHARMA LLC
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 15MG BASE TABLET;ORAL Prescription No AB 072735 HIKMA
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 15MG BASE TABLET;ORAL Prescription No AB 211132 INGENUS PHARMS LLC
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 15MG BASE TABLET;ORAL Prescription No AB 213929 LEADING

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 INGENUS PHARMS LLC
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 25MG BASE TABLET;ORAL Prescription No AB 213929 LEADING
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