Drugs@FDA: FDA-Approved Drugs
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIBAVIRIN | RIBAVIRIN | 200MG | CAPSULE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/17/2009 | 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 |
---|---|---|---|---|---|
03/22/2023 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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04/14/2021 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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04/14/2021 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/14/2021 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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01/11/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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05/19/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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05/19/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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05/19/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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11/16/2011 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
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04/02/2010 | SUPPL-1 | Labeling-Container/Carton Labels, REMS-Proposal, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
RIBAVIRIN
CAPSULE;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RIBAVIRIN | RIBAVIRIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 079117 | AUROBINDO PHARMA |
RIBAVIRIN | RIBAVIRIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 077224 | ZYDUS PHARMS USA |