Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 015500
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLINASE TOLAZAMIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
TOLINASE TOLAZAMIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
TOLINASE TOLAZAMIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
07/18/1966 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/1999 SUPPL-50 Labeling

Label is not available on this site.

06/25/1987 SUPPL-48 Labeling

Label is not available on this site.

06/25/1987 SUPPL-47 Labeling

Label is not available on this site.

07/11/1986 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1986 SUPPL-45 Labeling

Label is not available on this site.

10/03/1984 SUPPL-43 Labeling

Label is not available on this site.

05/09/1983 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1978 SUPPL-40 Labeling

Label is not available on this site.

12/01/1975 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

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