Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076192
Company: CASI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription AB 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
04/06/2004 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76192lbl_Ribavarin_Sandoz.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76192ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/11/2016 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/08/2014 SUPPL-18 Labeling-Patient Package Insert

Label is not available on this site.

07/08/2014 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

07/08/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

08/01/2011 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

07/21/2008 SUPPL-12 Labeling

Label is not available on this site.

01/04/2008 SUPPL-11 Labeling

Label is not available on this site.

03/28/2006 SUPPL-3 Labeling

Label is not available on this site.

09/15/2004 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/06/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76192lbl_Ribavarin_Sandoz.pdf

RIBAVIRIN

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REBETOL RIBAVIRIN 200MG CAPSULE;ORAL Prescription Yes AB 020903 MERCK SHARP DOHME
RIBASPHERE RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 076203 KADMON PHARMS LLC
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 079117 AUROBINDO PHARMA
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 076192 CASI PHARMS INC
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 076277 TEVA
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 077224 ZYDUS PHARMS USA

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