Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018459
Company: XANODYNE PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 5MG BASE TABLET;ORAL Discontinued None 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
02/08/1980 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
10/09/2001 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/25/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/24/1996 SUPPL-12 Labeling

Label is not available on this site.

11/21/1991 SUPPL-11 Labeling

Label is not available on this site.

07/26/1989 SUPPL-8 Labeling

Label is not available on this site.

03/30/1987 SUPPL-6 Labeling

Label is not available on this site.

03/05/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/04/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/04/1988 SUPPL-2 Labeling

Label is not available on this site.

11/05/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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