Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011338
Company: WYETH AYERST

Products on NDA 011338

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOTHANE	HALOTHANE	99.99% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	LIQUID;INHALATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011338

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/1958	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/1996	SUPPL-18	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
04/29/1996	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/28/1994	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/30/1987	SUPPL-15	Labeling		Label is not available on this site.
07/30/1987	SUPPL-14	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
10/01/1982	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
12/03/1981	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
12/01/1981	SUPPL-9	Labeling		Label is not available on this site.
12/01/1981	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/1979	SUPPL-7	Labeling		Label is not available on this site.
10/23/1978	SUPPL-6	Labeling		Label is not available on this site.
10/28/1975	SUPPL-5	Labeling		Label is not available on this site.
10/28/1975	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.