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Abbreviated New Drug Application (ANDA): 090681
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
05/09/2017 ORIG-2 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090681Orig1s000TAltr.pdf
11/01/2016 ORIG-1 Approval Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/090681Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090681Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090681Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/19/2023 SUPPL-13 Labeling-Container/Carton Labels

Label is not available on this site.

04/19/2023 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/19/2023 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/19/2023 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/19/2023 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/19/2023 SUPPL-5 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
11/01/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/090681Orig1s000lbl.pdf

QUETIAPINE FUMARATE

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
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211144 GRAVITI PHARMS
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 208781 PRINSTON INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209635 SCIEGEN PHARMS 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
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211144 GRAVITI PHARMS
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 208781 PRINSTON INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209635 SCIEGEN PHARMS 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
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211144 GRAVITI PHARMS
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 208781 PRINSTON INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209635 SCIEGEN PHARMS 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
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211144 GRAVITI PHARMS
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 208781 PRINSTON INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209635 SCIEGEN PHARMS 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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