Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071357
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLAZAMIDE TOLAZAMIDE 100MG 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-18 Labeling

Label is not available on this site.

05/16/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/03/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/08/1991 SUPPL-2 Labeling

Label is not available on this site.

06/18/1991 SUPPL-1 Labeling

Label is not available on this site.

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