Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013264
Company: LEDERLE

Products on NDA 013264

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROMOX	QUINETHAZONE	50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 013264

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/1963	ORIG-1	Approval	Type 1 - New Molecular Entity	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
07/15/1987	SUPPL-26	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/15/1983	SUPPL-25	Manufacturing (CMC)-Formulation		Label is not available on this site.
05/21/1982	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
02/21/1980	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
06/28/1978	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
06/28/1978	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
06/07/1978	SUPPL-20	Labeling		Label is not available on this site.