Drugs@FDA: FDA Approved Drug Products

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

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 072733 WEST-WARD PHARMS INT

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