Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010670
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORINASE TOLBUTAMIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
ORINASE TOLBUTAMIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
05/31/1957 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
10/27/1987 SUPPL-48 Labeling

Label is not available on this site.

12/19/1986 SUPPL-46 Labeling

Label is not available on this site.

03/24/1986 SUPPL-45 Labeling

Label is not available on this site.

10/18/1984 SUPPL-44 Labeling

Label is not available on this site.

12/08/1977 SUPPL-34 Labeling

Label is not available on this site.

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