FDA.reportPublic FDA data

Application 077304

Type
ANDA
Sponsor
EXELA PHARMA SCS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAFFEINE CITRATECAFFEINE CITRATESOLUTION;ORALEQ 30MG BASE/3ML (EQ 10MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51754-0501caffeine citrateCAFFEINE CITRATEExela Pharma Sciences, LLCANDACurrent
51754-0501caffeine citrateCAFFEINE CITRATEExela Pharma Sciences, LLCANDACurrent
51754-0503caffeine citrateCAFFEINE CITRATEExela Pharma Sciences, LLCANDACurrent
51754-0503caffeine citrateCAFFEINE CITRATEExela Pharma Sciences, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31220ORIG2006-09-25