Drugs@FDA: FDA-Approved Drugs
Company: HERITAGE PHARMA AVET
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIBAVIRIN | RIBAVIRIN | 200MG | 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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077053ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/08/2023 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
04/30/2013 | SUPPL-13 | Labeling-Medication Guide |
Label is not available on this site. |
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03/18/2011 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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01/10/2011 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
01/12/2011 | SUPPL-10 | REMS-Proposal |
Label is not available on this site. |
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09/08/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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05/11/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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03/08/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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01/14/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
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06/30/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
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03/07/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
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04/10/2006 | SUPPL-1 | Labeling |
Label is not available on this site. |