Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071198
Company: BARR

Products on ANDA 071198

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071198

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/1987	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-43	Labeling-Package Insert		Label is not available on this site.
12/26/2000	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
04/21/2000	SUPPL-29	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
04/21/2000	SUPPL-28	Manufacturing (CMC)-Facility		Label is not available on this site.
12/21/1999	SUPPL-27	Manufacturing (CMC)-Facility		Label is not available on this site.
09/16/1999	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
05/20/1999	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
07/24/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
11/10/1997	SUPPL-22	Labeling		Label is not available on this site.
06/20/1997	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/20/1997	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/07/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
02/10/1995	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/16/1992	SUPPL-15	Labeling		Label is not available on this site.
04/03/1992	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/18/1990	SUPPL-11	Labeling		Label is not available on this site.
02/23/1991	SUPPL-10	Labeling		Label is not available on this site.
02/23/1991	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/23/1991	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/23/1991	SUPPL-7	Labeling		Label is not available on this site.
02/23/1991	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/20/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/20/1989	SUPPL-4	Labeling		Label is not available on this site.
03/20/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/20/1989	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 071198

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