Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG 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)
Letter (PDF) Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090120s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/08/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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02/08/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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02/08/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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02/08/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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12/11/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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12/11/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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06/30/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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06/30/2017 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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08/25/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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08/25/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
QUETIAPINE FUMARATE
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 |