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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206260
Company: PHARMADAX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;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
05/09/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206260Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206260Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/20/2023 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/20/2023 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/20/2023 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/28/2019 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/03/2019 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206260Orig1s000lbl.pdf
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