FDA.reportPublic FDA data

Application 204326

Type
NDA
Sponsor
NEOS THERAPS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADZENYS XR-ODTAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 3.1MG BASEYesNo
002ADZENYS XR-ODTAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 6.3MG BASEYesNo
003ADZENYS XR-ODTAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 9.4MG BASEYesNo
004ADZENYS XR-ODTAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 12.5MG BASEYesNo
005ADZENYS XR-ODTAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 15.7MG BASEYesNo
006ADZENYS XR-ODTAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 18.8MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70165-005Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-005Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-005Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent
70165-005Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent
70165-010Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent
70165-010Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-010Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-010Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent
70165-015Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent
70165-015Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-015Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-015Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent
70165-020Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent
70165-020Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent
70165-020Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-020Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-025Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent
70165-025Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-025Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-025Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent
70165-030Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent
70165-030Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-030Adzenys XR-ODTAmphetamineNeos Therapeutics, LPNDACurrent
70165-030Adzenys XR-ODTAmphetamineNeos Therapeutics Brands, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81808SUPPL 2025-12-12
83487SUPPL 2025-09-25
83486SUPPL 2025-09-25
83448SUPPL 2025-09-25
83002SUPPL 2025-07-31
82995SUPPL 2025-07-31
81872SUPPL 2025-04-08
78093SUPPL 2024-04-09
78092SUPPL 2024-04-09
75781SUPPL 2023-10-17
75772SUPPL 2023-10-16
70388SUPPL2022-03-03
70386SUPPL2022-03-03
70298SUPPL2022-02-28
67753SUPPL2021-06-09
46727SUPPL2017-01-09
46685SUPPL2017-01-06
46434ORIG2016-12-21
45987SUPPL2016-12-01
45923SUPPL2016-11-22
45922ORIG2016-01-28
45921ORIG2016-01-28
51526ORIG1900-01-01
51525ORIG1900-01-01