FDA.reportPublic FDA data

Application 207987

Type
NDA
Sponsor
BELCHER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABLYSINOLALCOHOLSOLUTION;INTRA-ARTERIAL99% (1ML)YesNo
002ABLYSINOLALCOHOLSOLUTION;INTRA-ARTERIAL99% (5ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54288-105Dehydrated AlcoholAlcoholBPI Labs, LLCNDACurrent
54288-105Dehydrated AlcoholAlcoholBPI Labs, LLCNDACurrent
54288-105Dehydrated AlcoholAlcoholBPI Labs, LLCNDACurrent
54288-105Dehydrated AlcoholAlcoholBPI Labs, LLCNDACurrent
54288-105Dehydrated AlcoholAlcoholBPI Labs, LLCNDACurrent
62250-105Dehydrated AlcoholAlcoholBelcher Pharmaceuticals, LLCNDACurrent
62250-105Dehydrated AlcoholAlcoholBelcher Pharmaceuticals, LLCNDACurrent
62250-105Dehydrated AlcoholAlcoholBelcher Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85647SUPPL 2026-04-07
85646SUPPL 2026-04-07
59126ORIG2019-06-19
54747ORIG2018-07-04
54702ORIG2018-06-27