Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070269
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALLOPURINOL ALLOPURINOL 300MG 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
12/31/1985 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
05/09/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/20/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/26/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/26/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/15/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/15/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/08/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/27/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/11/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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