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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090120
Company: HIKMA

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

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 Letter (PDF)
Letter (PDF)
Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090120s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2025 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
02/08/2023 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
02/08/2023 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
02/08/2023 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
02/08/2023 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
12/11/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
12/11/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
06/30/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
06/30/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
08/25/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
08/25/2015 SUPPL-2 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 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 204316 HETERO LABS LTD V
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 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 206954 PRINSTON INC
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 077380 RISING
QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 090960 SCIEGEN PHARMS
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 202674 UNICHEM
SEROQUEL QUETIAPINE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription Yes AB 020639 CHEPLAPHARM
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