Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072734
Company: HIKMA

Products on ANDA 072734

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072734

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/1993	ORIG-1	Approval				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-11	Labeling-Package Insert		Label is not available on this site.
11/07/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
10/22/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
11/07/1997	SUPPL-5	Labeling		Label is not available on this site.
08/28/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/04/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/04/1994	SUPPL-2	Labeling		Label is not available on this site.
11/04/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 072734

LEUCOVORIN CALCIUM

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