FDA.reportPublic FDA data

Application 212797

Type
ANDA
Sponsor
XIAMEN LP PHARM CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL0.375MGNoNo
002PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL0.75MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69680-145Pramipexole DihydrochloridePramipexole DihydrochlorideVitruvias Therapeutics, Inc.ANDACurrent
69680-145Pramipexole DihydrochloridePramipexole DihydrochlorideVitruvias Therapeutics, Inc.ANDACurrent
69680-146Pramipexole DihydrochloridePramipexole DihydrochlorideVitruvias Therapeutics, Inc.ANDACurrent
69680-146Pramipexole DihydrochloridePramipexole DihydrochlorideVitruvias Therapeutics, Inc.ANDACurrent
71034-002Pramipexole DihydrochloridePramipexole DihydrochlorideXiamen LP Pharmaceutical Co., Ltd.ANDACurrent
71034-003Pramipexole DihydrochloridePramipexole DihydrochlorideXiamen LP Pharmaceutical Co., Ltd.ANDACurrent