Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090749
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090749s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/11/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/11/2019 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/22/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/22/2017 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/04/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/04/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

QUETIAPINE FUMARATE

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English