FDA.reportPublic FDA data

Application 205489

Type
NDA
Sponsor
NEOS THERAPS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COTEMPLA XR-ODTMETHYLPHENIDATETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL8.6MGYesNo
002COTEMPLA XR-ODTMETHYLPHENIDATETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL17.3MGYesNo
003COTEMPLA XR-ODTMETHYLPHENIDATETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL25.9MGYesNo
004COTEMPLA XR-ODTMETHYLPHENIDATETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL34.6MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70165-100Cotempla XR-ODTMethylphenidateNeos Therapeutics, LPNDACurrent
70165-100Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent
70165-100Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent
70165-100Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent
70165-100Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent
70165-100Cotempla XR-ODTMethylphenidateNeos Therapeutics, LPNDACurrent
70165-200Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent
70165-200Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent
70165-200Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent
70165-200Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent
70165-200Cotempla XR-ODTMethylphenidateNeos Therapeutics, LPNDACurrent
70165-200Cotempla XR-ODTMethylphenidateNeos Therapeutics, LPNDACurrent
70165-300Cotempla XR-ODTMethylphenidateNeos Therapeutics, LPNDACurrent
70165-300Cotempla XR-ODTMethylphenidateNeos Therapeutics, LPNDACurrent
70165-300Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent
70165-300Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent
70165-300Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent
70165-300Cotempla XR-ODTMethylphenidateNeos Therapeutics Brands, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83489SUPPL 2025-09-25
83488SUPPL 2025-09-25
83449SUPPL 2025-09-25
78400SUPPL 2024-05-06
78396SUPPL 2024-05-06
75771SUPPL 2023-10-16
75731SUPPL 2023-10-16
67955SUPPL2021-06-29
67954SUPPL2021-06-29
67938SUPPL2021-06-29
52883ORIG2018-03-09
48790ORIG2017-06-22
48787ORIG2017-06-20
48786ORIG2017-06-19
51372ORIG1900-01-01
51371ORIG1900-01-01
51370ORIG1900-01-01
51369ORIG1900-01-01
51367ORIG1900-01-01