Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076762
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE;ORAL Prescription AB No No
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE;ORAL Prescription AB No No
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE;ORAL Prescription AB No No
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/01/2004 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-11 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/18/2009 SUPPL-7 Labeling

Label is not available on this site.

04/23/2009 SUPPL-5 Labeling

Label is not available on this site.

08/18/2008 SUPPL-4 Labeling

Label is not available on this site.

LOXAPINE SUCCINATE

CAPSULE;ORAL; EQ 5MG 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 5MG BASE CAPSULE;ORAL Prescription No AB 076868 ELITE LABS INC
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 090695 LANNETT HOLDINGS INC
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 076762 MYLAN
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 072204 WATSON LABS

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 HOLDINGS INC
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 076762 MYLAN
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 072205 WATSON LABS

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

CAPSULE;ORAL; EQ 50MG 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 50MG BASE CAPSULE;ORAL Prescription No AB 076868 ELITE LABS INC
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 090695 LANNETT HOLDINGS INC
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 076762 MYLAN
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 072062 WATSON LABS

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