Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072206
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE;ORAL Prescription AB No Yes
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-34 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-28 Labeling

Label is not available on this site.

05/27/2009 SUPPL-27 Labeling

Label is not available on this site.

09/08/2008 SUPPL-25 Labeling

Label is not available on this site.

09/03/2008 SUPPL-22 Labeling

Label is not available on this site.

06/17/2002 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/2002 SUPPL-11 Labeling

Label is not available on this site.

03/29/2000 SUPPL-10 Labeling

Label is not available on this site.

01/14/2000 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/29/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/25/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/13/1997 SUPPL-6 Labeling

Label is not available on this site.

07/31/1992 SUPPL-5 Labeling

Label is not available on this site.

02/01/1991 SUPPL-4 Labeling

Label is not available on this site.

04/11/1989 SUPPL-3 Labeling

Label is not available on this site.

LOXAPINE SUCCINATE

CAPSULE;ORAL; EQ 25MG 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 25MG BASE CAPSULE;ORAL Prescription No AB 076868 ELITE LABS INC
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 090695 LANNETT HOLDINGS INC
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 076762 MYLAN
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 072206 WATSON LABS

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