FDA.reportPublic FDA data

Application 076203

Type
ANDA
Sponsor
KADMON PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIBASPHERERIBAVIRINCAPSULE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54738-953ribavirinribavirinRichmond Pharmaceuticals, Inc.ANDACurrent
66435-101RibasphereRibavirinKadmon Pharmaceuticals, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43895ORIG2009-11-20
44435ORIG2004-04-09
18445ORIG2004-04-09
8877ORIG2004-04-07