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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076762
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE;ORAL Discontinued None No No
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE;ORAL Discontinued None No No
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE;ORAL Discontinued None No No
LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE;ORAL Discontinued None 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.

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