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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016904
Company: PFIZER

Products on NDA 016904

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAVANE	THIOTHIXENE HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
NAVANE	THIOTHIXENE HYDROCHLORIDE	EQ 10MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016904

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/1971	ORIG-1	Approval	Type 2 - New Active Ingredient	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
07/19/2009	SUPPL-34	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016584s059,016758s020,016904s034ltr.pdf
04/07/2008	SUPPL-33	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016584s057, 016758s019, 016904s033ltr.pdf
08/02/1996	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
07/25/1996	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
07/15/1994	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
07/19/1989	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
12/10/1987	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
08/26/1985	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/17/1984	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/08/1983	SUPPL-18	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/10/1984	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
01/18/1982	SUPPL-14	Labeling		Label is not available on this site.
01/18/1982	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/10/1980	SUPPL-11	Labeling		Label is not available on this site.
06/02/1981	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
09/21/1979	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
10/12/1979	SUPPL-8	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 016904

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/19/2009	SUPPL-34	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf
04/07/2008	SUPPL-33	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf

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