FDA.reportPublic FDA data

Application 077094

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIBAVIRINRIBAVIRINTABLET;ORAL200MGNoNo
002RIBAVIRINRIBAVIRINTABLET;ORAL400MGNoNo
003RIBAVIRINRIBAVIRINTABLET;ORAL600MGNoNo
004RIBAVIRINRIBAVIRINTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-046RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-046RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-046RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-046RibavirinRibavirinZydus Lifesciences LimitedANDACurrent
65841-046RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-129RibavirinRibavirinZydus Lifesciences LimitedANDACurrent
65841-129RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-129RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-129RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-129RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-603RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-603RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-603RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-603RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-603RibavirinRibavirinZydus Lifesciences LimitedANDACurrent
65841-632RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-632RibavirinRibavirinZydus Lifesciences LimitedANDACurrent
65841-632RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-632RibavirinRibavirinCadila Healthcare LimitedANDACurrent
65841-632RibavirinRibavirinCadila Healthcare LimitedANDACurrent
68382-046RibavirinRibavirinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-046RibavirinRibavirinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-046RibavirinRibavirinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-127RibavirinRibavirinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-127RibavirinRibavirinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-127RibavirinRibavirinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-128RibavirinRibavirinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-128RibavirinRibavirinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-128RibavirinRibavirinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-129RibavirinRibavirinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-129RibavirinRibavirinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-129RibavirinRibavirinZydus Pharmaceuticals (USA) Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31196ORIG2005-10-20