Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087318
Company: WATSON LABS

Products on ANDA 087318

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 087318

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/1981	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
08/08/1991	SUPPL-22	Labeling		Label is not available on this site.
07/10/1991	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
07/10/1991	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
01/28/1991	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
05/06/1988	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/06/1988	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
05/02/1985	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/02/1985	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/08/1984	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/17/1984	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/17/1984	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/17/1984	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/16/1982	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.