Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072736
Company: WEST-WARD PHARMS INT
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 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
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
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.

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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