Drugs@FDA: FDA Approved Drug Products

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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 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
05/09/2017 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
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

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 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 090482 PAR PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206260 PHARMADAX INC
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 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 090482 PAR PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206260 PHARMADAX INC
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 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 090482 PAR PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206260 PHARMADAX INC
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 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 090482 PAR PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206260 PHARMADAX INC
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 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 090482 PAR PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206260 PHARMADAX INC
SEROQUEL XR QUETIAPINE FUMARATE EQ 400MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022047 ASTRAZENECA

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