Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022047
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEROQUEL XR | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| SEROQUEL XR | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| SEROQUEL XR | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| SEROQUEL XR | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| SEROQUEL XR | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 05/17/2007 | ORIG-1 | Approval | Type 3 - New Dosage Form | UNKNOWN |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022047Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022047s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/27/2022 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022047s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020639Orig1s072; 022047Orig1s046ltr.pdf | |
| 09/18/2020 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022047s041s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020639Orig1sS070, 022047Orig1s041, 022047s044ltr.pdf | |
| 02/05/2020 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022047s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020639Orig1s069, 022047Orig1s043ltr.pdf | |
| 03/27/2020 | SUPPL-42 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022047Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022047Orig1s042ltr.pdf | |
| 09/18/2020 | SUPPL-41 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020639Orig1sS070, 022047Orig1s041, 022047s044ltr.pdf |
| 08/26/2019 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022047s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020639Orig1s066, 022047Orig1s040ltr.pdf | |
| 02/23/2017 | SUPPL-39 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022047s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020639Orig1s065,022047Orig1s039ltr.pdf | |
| 06/17/2016 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022047s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020639Orig1s064,022047Orig1s038ltr.pdf | |
| 11/29/2018 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022047s033s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020639Orig1s060, s063, 022047Orig1s033, s037ltr.pdf | |
| 01/26/2015 | SUPPL-36 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022047s036lbl.pdf | |
| 10/29/2013 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s061,022047Orig1s034ltr.pdf | |
| 11/29/2018 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022047s033s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020639Orig1s060, s063, 022047Orig1s033, s037ltr.pdf | |
| 04/30/2013 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf | |
| 04/30/2013 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf | |
| 04/30/2013 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf | |
| 11/09/2011 | SUPPL-28 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s028ltr.pdf |
| 07/08/2011 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s023s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s023,s027ltr.pdf | |
| 04/30/2013 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf | |
| 12/01/2010 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022047s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022047s025ltr.pdf | |
| 05/17/2011 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s024ltr.pdf | |
| 07/08/2011 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s023s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s023,s027ltr.pdf | |
| 12/02/2009 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf | |
| 12/02/2009 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf | |
| 08/14/2008 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s018ltr.pdf |
| 12/02/2009 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf | |
| 12/02/2009 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf | |
| 08/11/2008 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s013ltr.pdf | |
| 12/02/2009 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022047Orig1s011.pdf | |
| 05/21/2008 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s009ltr.pdf |
| 10/08/2008 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf | |
| 10/08/2008 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf | |
| 10/08/2008 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf | |
| 03/13/2008 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/27/2022 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022047s046lbl.pdf | |
| 09/18/2020 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022047s041s044lbl.pdf | |
| 03/27/2020 | SUPPL-42 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022047Orig1s042lbl.pdf | |
| 03/27/2020 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022047Orig1s042lbl.pdf | |
| 02/05/2020 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022047s043lbl.pdf | |
| 08/26/2019 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022047s040lbl.pdf | |
| 11/29/2018 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022047s033s037lbl.pdf | |
| 11/29/2018 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022047s033s037lbl.pdf | |
| 02/23/2017 | SUPPL-39 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022047s039lbl.pdf | |
| 02/23/2017 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022047s039lbl.pdf | |
| 06/17/2016 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022047s038lbl.pdf | |
| 01/26/2015 | SUPPL-36 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022047s036lbl.pdf |
| 10/29/2013 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s034lbl.pdf | |
| 04/30/2013 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf | |
| 04/30/2013 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf | |
| 04/30/2013 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf | |
| 04/30/2013 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf | |
| 07/08/2011 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s023s027lbl.pdf | |
| 07/08/2011 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s023s027lbl.pdf | |
| 05/17/2011 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s024lbl.pdf | |
| 12/01/2010 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022047s025lbl.pdf | |
| 12/02/2009 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf | |
| 12/02/2009 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf | |
| 12/02/2009 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf | |
| 12/02/2009 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf | |
| 12/02/2009 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf | |
| 10/08/2008 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf | |
| 10/08/2008 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf | |
| 10/08/2008 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf | |
| 08/11/2008 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s013lbl.pdf | |
| 08/11/2008 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s013lbl.pdf | |
| 03/13/2008 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s002lbl.pdf |
SEROQUEL XR
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 | 206252 | ACCORD HLTHCARE |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207655 | AUROBINDO PHARMA |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211144 | GRAVITI PHARMS |
| 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 | 208947 | NOVAST LABS |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208781 | PRINSTON INC |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209635 | SCIEGEN PHARMS INC |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215478 | UNICHEM |
| SEROQUEL XR | QUETIAPINE FUMARATE | EQ 50MG 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 | 209497 | ALIGNSCIENCE PHARMA |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207655 | AUROBINDO PHARMA |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211144 | GRAVITI PHARMS |
| 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 | 204253 | MACLEODS PHARMS LTD |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208947 | NOVAST LABS |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208781 | PRINSTON INC |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209635 | SCIEGEN PHARMS INC |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215478 | UNICHEM |
| 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 | 207655 | AUROBINDO PHARMA |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211144 | GRAVITI PHARMS |
| 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 | 204253 | MACLEODS PHARMS LTD |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208947 | NOVAST LABS |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208781 | PRINSTON INC |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209635 | SCIEGEN PHARMS INC |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215478 | UNICHEM |
| 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 | 207655 | AUROBINDO PHARMA |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211144 | GRAVITI PHARMS |
| 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 | 204253 | MACLEODS PHARMS LTD |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208947 | NOVAST LABS |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208781 | PRINSTON INC |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209635 | SCIEGEN PHARMS INC |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215478 | UNICHEM |
| SEROQUEL XR | QUETIAPINE FUMARATE | EQ 400MG 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 | 209497 | ALIGNSCIENCE PHARMA |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207655 | AUROBINDO PHARMA |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211144 | GRAVITI PHARMS |
| 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 | 204253 | MACLEODS PHARMS LTD |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208947 | NOVAST LABS |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208781 | PRINSTON INC |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209635 | SCIEGEN PHARMS INC |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215478 | UNICHEM |
| SEROQUEL XR | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022047 | ASTRAZENECA |