FDA.reportPublic FDA data

Application 077456

Type
ANDA
Sponsor
KADMON PHARMS LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3197ModeribaRibavirinAbbVie Inc.ANDACurrent
0074-3282ModeribaRibavirinAbbVie Inc.ANDACurrent
54738-950ribavirinribavirinRichmond Pharmaceuticals, Inc.ANDACurrent
54738-951ribavirinribavirinRichmond Pharmaceuticals, Inc.ANDACurrent
54738-952ribavirinribavirinRichmond Pharmaceuticals, Inc.ANDACurrent
66435-102RIBASPHEREribavirinKadmon Pharmaceuticals, LLCANDACurrent
66435-103RIBASPHEREribavirinKadmon Pharmaceuticals, LLCANDACurrent
66435-104RIBASPHEREribavirinKadmon Pharmaceuticals, LLCANDACurrent
66435-105RIBASPHERE RibaPakribavirinKadmon Pharmaceuticals, LLCANDACurrent
66435-106RIBASPHERE RibaPakribavirinKadmon Pharmaceuticals, LLCANDACurrent
66435-107RIBASPHERE RibaPakribavirinKadmon Pharmaceuticals, LLCANDACurrent
66435-108RIBASPHERE RibaPakribavirinKadmon Pharmaceuticals, LLCANDACurrent