Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206252
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 50MG 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 |
---|---|---|---|---|---|---|---|
11/29/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/19/2023 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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04/20/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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04/20/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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04/20/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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04/20/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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04/20/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
QUETIAPINE FUMARATE
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 | 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 | 206260 | PHARMADAX INC |
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 |