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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018039
Company: ACTAVIS LABS UT INC

Products on NDA 018039

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOXITANE IM	LOXAPINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018039

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/1979	ORIG-1	Approval	Type 3 - New Dosage Form	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
02/23/2017	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017658Orig1s038,018039Orig1s024,017525Orig1s051ltr.pdf
09/16/1998	SUPPL-23	Labeling		Label is not available on this site.
11/21/1994	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
06/29/1994	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
03/25/1994	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
02/03/1987	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
11/20/1984	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
03/10/1983	SUPPL-7	Labeling		Label is not available on this site.
10/17/1983	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
10/08/1981	SUPPL-5	Labeling		Label is not available on this site.
02/20/1980	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/06/1981	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/16/1980	SUPPL-2	Labeling		Label is not available on this site.
09/16/1980	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018039

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2017	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf

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