FDA.reportPublic FDA data

Application 208944

Type
NDA
Sponsor
ADAMAS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GOCOVRIAMANTADINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 68.5MG BASEYesNo
002GOCOVRIAMANTADINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 137MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70482-085GOCOVRIAMANTADINEAdamas Pharma, LLCNDACurrent
70482-085GOCOVRIAMANTADINEAdamas Pharma, LLCNDACurrent
70482-085GOCOVRIAMANTADINEAdamas Pharma, LLCNDACurrent
70482-085GOCOVRIAMANTADINEAdamas Pharma, LLCNDACurrent
70482-085GOCOVRIAMANTADINEAdamas Pharma, LLCNDACurrent
70482-170GOCOVRIAMANTADINEAdamas Pharma, LLCNDACurrent
70482-170GOCOVRIAMANTADINEAdamas Pharma, LLCNDACurrent
70482-170GOCOVRIAMANTADINEAdamas Pharma, LLCNDACurrent
70482-170GOCOVRIAMANTADINEAdamas Pharma, LLCNDACurrent
70482-170GOCOVRIAMANTADINEAdamas Pharma, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82814SUPPL 2025-07-11
82791SUPPL 2025-07-11
66076SUPPL2021-02-03
66058SUPPL2021-02-02
62115SUPPL2020-03-11
62128SUPPL2020-03-10
54735ORIG2018-07-02
49540ORIG2017-08-25
49536ORIG2017-08-25