Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071962
Company: XANODYNE PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 10MG 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
11/19/1987 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
04/28/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/21/1991 SUPPL-9 Labeling

Label is not available on this site.

07/29/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/29/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-5 Labeling

Label is not available on this site.

11/04/1988 SUPPL-3 Labeling

Label is not available on this site.

11/04/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/04/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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