Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083234
Company: UPSHER SMITH LABS

Products on ANDA 083234

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083234

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/1976	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
01/19/2000	SUPPL-54	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/08/1991	SUPPL-52	Labeling		Label is not available on this site.
01/15/1987	SUPPL-51	Manufacturing (CMC)		Label is not available on this site.
10/30/1986	SUPPL-50	Manufacturing (CMC)		Label is not available on this site.
11/19/1984	SUPPL-48	Manufacturing (CMC)		Label is not available on this site.
06/01/1984	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
01/23/1984	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
01/23/1984	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
12/23/1982	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
01/27/1983	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
06/30/1982	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
06/30/1982	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
06/30/1982	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
06/30/1982	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
06/30/1982	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.