FDA.reportPublic FDA data

Application 207488

Type
ANDA
Sponsor
ABHAI LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL20MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10702-075METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEmethylphenidate hydrochloride extended releaseKVK-Tech, Inc.ANDACurrent
10702-075METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEmethylphenidate hydrochloride extended releaseKVK-Tech, Inc.ANDACurrent
10702-075METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEmethylphenidate hydrochloride extended releaseKVK-Tech, Inc.ANDACurrent
10702-076METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEmethylphenidate hydrochloride extended releaseKVK-Tech, Inc.ANDACurrent
10702-076METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEmethylphenidate hydrochloride extended releaseKVK-Tech, Inc.ANDACurrent
10702-076METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEmethylphenidate hydrochloride extended releaseKVK-Tech, Inc.ANDACurrent