Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018894
Company: COSETTE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLAZAMIDE TOLAZAMIDE 100MG TABLET;ORAL Discontinued None No No
TOLAZAMIDE TOLAZAMIDE 250MG TABLET;ORAL Discontinued None No No
TOLAZAMIDE TOLAZAMIDE 500MG 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
10/03/1984 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
07/29/2002 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

08/18/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/07/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/07/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/30/1995 SUPPL-10 Labeling

Label is not available on this site.

06/13/1994 SUPPL-9 Labeling

Label is not available on this site.

11/28/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/09/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/13/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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