Drugs@FDA: FDA-Approved Drugs
Company: ZYDUS PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIBAVIRIN | RIBAVIRIN | 200MG | TABLET;ORAL | Prescription | AB | No | No |
RIBAVIRIN | RIBAVIRIN | 400MG | TABLET;ORAL | Discontinued | None | No | No |
RIBAVIRIN | RIBAVIRIN | 600MG | TABLET;ORAL | Discontinued | None | No | No |
RIBAVIRIN | RIBAVIRIN | 500MG | 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/2005/077094TA_ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/25/2015 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
05/04/2015 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
05/04/2015 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/10/2011 | SUPPL-19 | REMS-Modified |
Label is not available on this site. |
||
03/10/2011 | SUPPL-18 | REMS-Proposal |
Label is not available on this site. |
||
09/16/2010 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
07/23/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
05/14/2008 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
01/04/2008 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
04/18/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
09/11/2014 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
03/20/2008 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/10/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/16/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/16/2007 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
RIBAVIRIN
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RIBAVIRIN | RIBAVIRIN | 200MG | TABLET;ORAL | Prescription | No | AB | 079111 | AUROBINDO PHARMA |
RIBAVIRIN | RIBAVIRIN | 200MG | TABLET;ORAL | Prescription | No | AB | 077743 | SANDOZ |
RIBAVIRIN | RIBAVIRIN | 200MG | TABLET;ORAL | Prescription | No | AB | 077094 | ZYDUS PHARMS USA |