Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012678
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLBUTAMIDE TOLBUTAMIDE 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
07/10/1974 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/26/1988 SUPPL-43 Labeling

Label is not available on this site.

09/02/1988 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1985 SUPPL-41 Labeling

Label is not available on this site.

06/28/1985 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

04/05/1985 SUPPL-39 Labeling

Label is not available on this site.

09/21/1983 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1988 SUPPL-36 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/07/2007 SUPPL-35 Labeling

Label is not available on this site.

09/21/1983 SUPPL-34 Labeling

Label is not available on this site.

12/07/2007 SUPPL-33 Labeling

Label is not available on this site.

12/07/2007 SUPPL-32 Labeling

Label is not available on this site.

12/07/2007 SUPPL-31 Labeling

Label is not available on this site.

12/07/2007 SUPPL-29 Labeling

Label is not available on this site.

12/07/2007 SUPPL-28 Labeling

Label is not available on this site.

12/08/1978 SUPPL-27 Labeling

Label is not available on this site.

12/11/1978 SUPPL-26 Labeling

Label is not available on this site.

12/07/2007 SUPPL-25 Labeling

Label is not available on this site.

12/07/2007 SUPPL-24 Labeling

Label is not available on this site.

12/07/2007 SUPPL-23 Labeling

Label is not available on this site.

05/30/1979 SUPPL-22 Labeling

Label is not available on this site.

05/30/1979 SUPPL-21 Labeling

Label is not available on this site.

05/30/1979 SUPPL-20 Labeling

Label is not available on this site.

05/30/1979 SUPPL-19 Labeling

Label is not available on this site.

12/07/2007 SUPPL-18 Labeling

Label is not available on this site.

12/07/2007 SUPPL-17 Labeling

Label is not available on this site.

12/07/2007 SUPPL-16 Labeling

Label is not available on this site.

12/07/2007 SUPPL-15 Labeling

Label is not available on this site.

12/07/2007 SUPPL-12 Labeling

Label is not available on this site.

12/07/2007 SUPPL-11 Labeling

Label is not available on this site.

01/23/1975 SUPPL-10 Labeling

Label is not available on this site.

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