Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071199
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
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-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1999 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

09/16/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/08/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/20/1997 SUPPL-13 Labeling

Label is not available on this site.

06/20/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/10/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/16/1992 SUPPL-7 Labeling

Label is not available on this site.

04/03/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/18/1990 SUPPL-3 Labeling

Label is not available on this site.

02/22/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

LEUCOVORIN CALCIUM

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 072736 WEST-WARD PHARMS INT

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