Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202546
Company: SANDOZ INC
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 Prescription AB No No
RIBAVIRIN RIBAVIRIN 500MG TABLET;ORAL Prescription AB No No
RIBAVIRIN RIBAVIRIN 600MG TABLET;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
08/12/2014 ORIG-1 Approval

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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 077456 KADMON PHARMS LLC
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 077743 SANDOZ
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 202546 SANDOZ INC
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 077053 TEVA
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 077094 ZYDUS PHARMS USA

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIBAVIRIN RIBAVIRIN 400MG TABLET;ORAL Prescription No AB 077456 KADMON PHARMS LLC
RIBAVIRIN RIBAVIRIN 400MG TABLET;ORAL Prescription No AB 202546 SANDOZ INC
RIBAVIRIN RIBAVIRIN 400MG TABLET;ORAL Prescription No AB 077094 ZYDUS PHARMS USA

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIBAVIRIN RIBAVIRIN 500MG TABLET;ORAL Prescription No AB 202546 SANDOZ INC
RIBAVIRIN RIBAVIRIN 500MG TABLET;ORAL Prescription No AB 077094 ZYDUS PHARMS USA

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIBAVIRIN RIBAVIRIN 600MG TABLET;ORAL Prescription No AB 077456 KADMON PHARMS LLC
RIBAVIRIN RIBAVIRIN 600MG TABLET;ORAL Prescription No AB 202546 SANDOZ INC
RIBAVIRIN RIBAVIRIN 600MG TABLET;ORAL Prescription No AB 077094 ZYDUS PHARMS USA

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