Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201190
Company: SUN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription AB No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription AB No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription AB No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription AB No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription AB No No
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;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
03/27/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/26/2017 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

09/26/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/14/2015 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/14/2015 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

QUETIAPINE FUMARATE

TABLET;ORAL; EQ 25MG 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 25MG BASE TABLET;ORAL Prescription No AB 202152 ACCORD HLTHCARE
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 203390 ALEMBIC PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 201504 ALKEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 091388 AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 077380 DR REDDYS LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 090120 HIKMA
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 203150 JUBILANT GENERICS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 201109 LUPIN LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 203359 MACLEODS PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 078679 SANDOZ
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 201190 SUN PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 077745 TEVA PHARMS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 200363 TORRENT PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 202674 UNICHEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 090960 ZENNOVA
SEROQUEL QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription Yes AB 020639 ASTRAZENECA PHARMS

TABLET;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;ORAL Prescription No AB 202152 ACCORD HLTHCARE
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 203390 ALEMBIC PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 201504 ALKEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 091388 AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 077380 DR REDDYS LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 090749 HIKMA
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 201109 LUPIN LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 203359 MACLEODS PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 078679 SANDOZ
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 201190 SUN PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 077745 TEVA PHARMS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 200363 TORRENT PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 202674 UNICHEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription No AB 090960 ZENNOVA
SEROQUEL QUETIAPINE FUMARATE EQ 50MG BASE TABLET;ORAL Prescription Yes AB 020639 ASTRAZENECA PHARMS

TABLET;ORAL; EQ 100MG 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 100MG BASE TABLET;ORAL Prescription No AB 202152 ACCORD HLTHCARE
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 203390 ALEMBIC PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 201504 ALKEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 091388 AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 077380 DR REDDYS LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 090749 HIKMA
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 201109 LUPIN LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 203359 MACLEODS PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 078679 SANDOZ
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 201190 SUN PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 077745 TEVA PHARMS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 200363 TORRENT PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 202674 UNICHEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription No AB 090960 ZENNOVA
SEROQUEL QUETIAPINE FUMARATE EQ 100MG BASE TABLET;ORAL Prescription Yes AB 020639 ASTRAZENECA PHARMS

TABLET;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;ORAL Prescription No AB 202152 ACCORD HLTHCARE
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 203390 ALEMBIC PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 201504 ALKEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 091388 AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 077380 DR REDDYS LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 090749 HIKMA
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 201109 LUPIN LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 203359 MACLEODS PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 078679 SANDOZ
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 201190 SUN PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 077745 TEVA PHARMS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 200363 TORRENT PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 202674 UNICHEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription No AB 090960 ZENNOVA
SEROQUEL QUETIAPINE FUMARATE EQ 200MG BASE TABLET;ORAL Prescription Yes AB 020639 ASTRAZENECA PHARMS

TABLET;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;ORAL Prescription No AB 202152 ACCORD HLTHCARE
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 203390 ALEMBIC PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 201504 ALKEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 091388 AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 077380 DR REDDYS LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 090749 HIKMA
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 201109 LUPIN LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 203359 MACLEODS PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 078679 SANDOZ
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 201190 SUN PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 077745 TEVA PHARMS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 200363 TORRENT PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 202674 UNICHEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription No AB 090960 ZENNOVA
SEROQUEL QUETIAPINE FUMARATE EQ 300MG BASE TABLET;ORAL Prescription Yes AB 020639 ASTRAZENECA PHARMS

TABLET;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;ORAL Prescription No AB 202152 ACCORD HLTHCARE
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 203390 ALEMBIC PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 201504 ALKEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 091388 AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 077380 DR REDDYS LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 090749 HIKMA
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 201109 LUPIN LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 203359 MACLEODS PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 078679 SANDOZ
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 201190 SUN PHARM
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 077745 TEVA PHARMS
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 200363 TORRENT PHARMS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 202674 UNICHEM LABS LTD
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription No AB 090960 ZENNOVA
SEROQUEL QUETIAPINE FUMARATE EQ 400MG BASE TABLET;ORAL Prescription Yes AB 020639 ASTRAZENECA PHARMS

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