Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071358
Company: SUN PHARM INDUSTRIES

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLAZAMIDE TOLAZAMIDE 250MG 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
07/16/1987 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
09/28/2006 SUPPL-20 Labeling

Label is not available on this site.
05/16/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.
05/16/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.
12/05/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
02/24/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
06/22/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
01/03/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
08/08/1991 SUPPL-4 Labeling

Label is not available on this site.
08/25/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
08/25/1988 SUPPL-2 Labeling

Label is not available on this site.
08/25/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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