Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072205
Company: WATSON LABS

Products on ANDA 072205

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072205

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/1988	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
02/23/2017	SUPPL-37	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/03/2010	SUPPL-30	Labeling		Label is not available on this site.
05/27/2009	SUPPL-29	Labeling		Label is not available on this site.
09/08/2008	SUPPL-27	Labeling		Label is not available on this site.
09/03/2008	SUPPL-24	Labeling		Label is not available on this site.
06/17/2002	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
12/02/2002	SUPPL-13	Labeling		Label is not available on this site.
03/29/2000	SUPPL-12	Labeling		Label is not available on this site.
01/14/2000	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/29/2000	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/25/1997	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/13/1997	SUPPL-8	Labeling		Label is not available on this site.
07/31/1992	SUPPL-7	Labeling		Label is not available on this site.
02/01/1991	SUPPL-6	Labeling		Label is not available on this site.
04/11/1989	SUPPL-4	Labeling		Label is not available on this site.
02/01/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 072205

LOXAPINE SUCCINATE

CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB	076868	ELITE LABS INC
LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB	090695	LANNETT CO INC
LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB	072205	WATSON LABS