Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012678
Company: SANDOZ

Products on NDA 012678

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOLBUTAMIDE	TOLBUTAMIDE	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012678

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.