Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078679
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/14/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/17/2022 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/17/2022 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/05/2015 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/05/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |