Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086926
Company: DAVA PHARMS INC

Products on ANDA 086926

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 ANDA 086926

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/1980	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
07/02/1991	SUPPL-11	Labeling		Label is not available on this site.
04/26/1991	SUPPL-10	Labeling		Label is not available on this site.
09/04/1987	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/24/1982	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/24/1982	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/24/1982	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/24/1982	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.