Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077456
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIBAVIRIN | RIBAVIRIN | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| RIBAVIRIN | RIBAVIRIN | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| RIBAVIRIN | RIBAVIRIN | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/05/2005 | 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 |
|---|---|---|---|---|---|
| 09/18/2017 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/06/2015 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 04/09/2014 | SUPPL-14 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/23/2011 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/27/2010 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2011 | SUPPL-10 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 02/11/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/18/2008 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 05/21/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 02/06/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |