Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090749
Company: HIKMA
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 |
|---|---|---|---|---|---|
| 02/08/2023 | SUPPL-15 | 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. |
||
| 02/08/2023 | SUPPL-10 | 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. |
||
| 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 | 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 | 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 |
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 | 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 | 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 | 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 | 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 |