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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204203
Company: LUPIN LTD
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 Prescription AB No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;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
05/17/2017 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
11/12/2021 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/12/2021 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/12/2021 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

11/12/2021 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/12/2021 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

11/12/2021 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

QUETIAPINE FUMARATE

TABLET, EXTENDED RELEASE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206252 ACCORD HLTHCARE
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207655 AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202939 INTELLIPHARMACEUTICS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204203 LUPIN LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208947 NOVAST LABS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090482 PAR PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206260 PHARMADAX INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208781 PRINSTON INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 215478 UNICHEM
SEROQUEL XR QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022047 ASTRAZENECA

TABLET, EXTENDED RELEASE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090681 ACCORD HLTHCARE
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209497 ALIGNSCIENCE PHARMA
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207655 AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202939 INTELLIPHARMACEUTICS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204203 LUPIN LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204253 MACLEODS PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208947 NOVAST LABS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090482 PAR PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206260 PHARMADAX INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208781 PRINSTON INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 215478 UNICHEM
SEROQUEL XR QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022047 ASTRAZENECA

TABLET, EXTENDED RELEASE;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090681 ACCORD HLTHCARE
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209497 ALIGNSCIENCE PHARMA
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207655 AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202939 INTELLIPHARMACEUTICS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204203 LUPIN LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204253 MACLEODS PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208947 NOVAST LABS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090482 PAR PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206260 PHARMADAX INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208781 PRINSTON INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 215478 UNICHEM
SEROQUEL XR QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022047 ASTRAZENECA

TABLET, EXTENDED RELEASE;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090681 ACCORD HLTHCARE
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207655 AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202939 INTELLIPHARMACEUTICS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204203 LUPIN LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204253 MACLEODS PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208947 NOVAST LABS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090482 PAR PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206260 PHARMADAX INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208781 PRINSTON INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 215478 UNICHEM
SEROQUEL XR QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022047 ASTRAZENECA

TABLET, EXTENDED RELEASE;ORAL; EQ 400MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090681 ACCORD HLTHCARE
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207655 AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202939 INTELLIPHARMACEUTICS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204203 LUPIN LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204253 MACLEODS PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208947 NOVAST LABS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090482 PAR PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206260 PHARMADAX INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 215478 UNICHEM
SEROQUEL XR QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022047 ASTRAZENECA
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