Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202266
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG 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 |
|---|---|---|---|---|---|---|---|
| 11/20/2012 | ORIG-2 | Approval |
Label is not available on this site. |
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| 08/14/2012 | 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 |
|---|---|---|---|---|---|
| 11/28/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/21/2021 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/24/2020 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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| 03/24/2020 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 03/24/2020 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/11/2015 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |