Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020639
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEROQUEL | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
| SEROQUEL | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| SEROQUEL | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| SEROQUEL | QUETIAPINE FUMARATE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| SEROQUEL | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
| SEROQUEL | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| SEROQUEL | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/26/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20639_seroquel_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/27/2022 | SUPPL-72 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020639s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020639Orig1s072; 022047Orig1s046ltr.pdf | |
| 09/18/2020 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020639s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020639Orig1sS070, 022047Orig1s041, 022047s044ltr.pdf | |
| 02/05/2020 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020639s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020639Orig1s069, 022047Orig1s043ltr.pdf | |
| 03/27/2020 | SUPPL-68 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020639Orig1s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020639Orig1s068ltr.pdf | |
| 08/26/2019 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020639s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020639Orig1s066, 022047Orig1s040ltr.pdf | |
| 02/23/2017 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020639s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020639Orig1s065,022047Orig1s039ltr.pdf | |
| 06/17/2016 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020639s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020639Orig1s064,022047Orig1s038ltr.pdf | |
| 11/29/2018 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020639s060s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020639Orig1s060, s063, 022047Orig1s033, s037ltr.pdf | |
| 10/29/2013 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s061,022047Orig1s034ltr.pdf | |
| 11/29/2018 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020639s060s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020639Orig1s060, s063, 022047Orig1s033, s037ltr.pdf | |
| 04/30/2013 | SUPPL-59 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf | |
| 04/30/2013 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf | |
| 04/30/2013 | SUPPL-57 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf | |
| 11/09/2011 | SUPPL-55 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s055ltr.pdf |
| 07/08/2011 | SUPPL-54 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s049,020639s054ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020639_seroquel_toc.cfm | |
| 04/30/2013 | SUPPL-53 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf | |
| 12/01/2010 | SUPPL-52 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020639s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020639s052ltr.pdf | |
| 05/17/2011 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s051ltr.pdf | |
| 07/08/2011 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s049,020639s054ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020639_seroquel_toc.cfm | |
| 12/02/2009 | SUPPL-46 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020639s045s046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/020639Orig1s046.pdf | |
| 12/02/2009 | SUPPL-45 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020639s045s046ltr.pdf | |
| 08/14/2008 | SUPPL-43 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s043ltr.pdf |
| 05/13/2008 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf | |
| 01/28/2008 | SUPPL-39 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s039ltr.pdf |
| 05/13/2008 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf | |
| 05/13/2008 | SUPPL-37 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020639s037.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020639se1-037_SUMR.pdf | |
| 07/30/2007 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020639s035ltr.pdf |
| 01/28/2008 | SUPPL-31 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s031ltr.pdf |
| 10/24/2008 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s030ltr.pdf |
| 10/20/2006 | SUPPL-26 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s026ltr.pdf | |
| 05/13/2008 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf | |
| 09/20/2006 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s023ltr.pdf | |
| 02/07/2006 | SUPPL-21 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s021ltr.pdf |
| 07/21/2004 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639s020ltr.pdf | |
| 01/12/2004 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639se1-017,016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020639_S016&S017_SEROQUEL TABLETS.pdf | |
| 01/12/2004 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639se1-017,016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020639_S016&S017_SEROQUEL TABLETS.pdf | |
| 12/06/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/2001 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/27/2001 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20639S11LTR.PDF |
| 11/06/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/2001 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/27/2022 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020639s072lbl.pdf | |
| 09/18/2020 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020639s070lbl.pdf | |
| 03/27/2020 | SUPPL-68 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020639Orig1s068lbl.pdf | |
| 03/27/2020 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020639Orig1s068lbl.pdf | |
| 02/05/2020 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020639s069lbl.pdf | |
| 08/26/2019 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020639s066lbl.pdf | |
| 11/29/2018 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020639s060s063lbl.pdf | |
| 11/29/2018 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020639s060s063lbl.pdf | |
| 02/23/2017 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020639s065lbl.pdf | |
| 06/17/2016 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020639s064lbl.pdf | |
| 10/29/2013 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s061lbl.pdf | |
| 04/30/2013 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf | |
| 04/30/2013 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf | |
| 04/30/2013 | SUPPL-57 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf | |
| 04/30/2013 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf | |
| 07/08/2011 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054lbl.pdf | |
| 07/08/2011 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054lbl.pdf | |
| 05/17/2011 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s051lbl.pdf | |
| 12/01/2010 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020639s052lbl.pdf | |
| 12/02/2009 | SUPPL-46 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf | |
| 12/02/2009 | SUPPL-45 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf | |
| 05/13/2008 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf | |
| 05/13/2008 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf | |
| 05/13/2008 | SUPPL-37 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf | |
| 05/13/2008 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf | |
| 10/20/2006 | SUPPL-26 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s026lbl.pdf | |
| 09/20/2006 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s023lbl.pdf | |
| 07/21/2004 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639s020lbl.pdf | |
| 01/12/2004 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf | |
| 01/12/2004 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf |
SEROQUEL
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 | 077380 | DR REDDYS LABS 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 | 205983 | IPCA LABS LTD |
| 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 | 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 | 202674 | UNICHEM |
| 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 |
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 | 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 | 204316 | HETERO LABS LTD V |
| 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 | 205983 | IPCA LABS LTD |
| 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 | 206954 | PRINSTON INC |
| 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 | 202674 | UNICHEM |
| 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 |
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 | 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 | 204316 | HETERO LABS LTD V |
| 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 | 205983 | IPCA LABS LTD |
| 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 | 206954 | PRINSTON INC |
| 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 | 202674 | UNICHEM |
| 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 |
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 | 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 | 204316 | HETERO LABS LTD V |
| 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 | 205983 | IPCA LABS LTD |
| 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 | 206954 | PRINSTON INC |
| 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 | 202674 | UNICHEM |
| 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 |
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 | 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 | 204316 | HETERO LABS LTD V |
| 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 | 205983 | IPCA LABS LTD |
| 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 | 206954 | PRINSTON INC |
| 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 | 202674 | UNICHEM |
| 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 |
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 | 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 | 204316 | HETERO LABS LTD V |
| 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 | 205983 | IPCA LABS LTD |
| 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 | 206954 | PRINSTON INC |
| 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 | 202674 | UNICHEM |
| 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 |