FDA.reportPublic FDA data

Application 204325

Type
NDA
Sponsor
NEOS THERAPS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADZENYS ERAMPHETAMINESUSPENSION, EXTENDED RELEASE;ORALEQ 1.25MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66993-360Amphetamine Extended-Release Oral SuspensionAmphetaminePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-360Amphetamine Extended-Release Oral SuspensionAmphetaminePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
70165-003Adzenys ERAmphetamineNeos Therapeutics, LPNDACurrent
70165-003Adzenys ERAmphetamineNeos Therapeutics, LPNDACurrent
70165-003Adzenys ERAmphetamineNeos Therapeutics Brands, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70318SUPPL2022-03-01
70317SUPPL2022-03-01
70297SUPPL2022-02-28
53638ORIG2018-04-09
52784ORIG2018-03-01
49766ORIG2017-09-18
49765ORIG2017-09-18
51524ORIG1900-01-01
51523ORIG1900-01-01