Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090681
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 05/09/2017 | ORIG-2 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090681Orig1s000TAltr.pdf | ||
| 11/01/2016 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/090681Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090681Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090681Orig1s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/19/2023 | SUPPL-13 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/19/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/01/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/090681Orig1s000lbl.pdf |
QUETIAPINE FUMARATE
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 |
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 |