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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203390
Company: ALEMBIC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Discontinued None No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Discontinued None No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Discontinued None No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Discontinued None No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Discontinued None No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;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
10/28/2014 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
06/30/2017 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/30/2017 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
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