Pramipexole Dihydrochloride

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6 Drugs in Development

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 16 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 16 Corel Pharma Chem, 2 DFE Pharma, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 18 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 11 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Vasa Pharmachem

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USFDA APPLICATION NUMBER - 20667 / DOSAGE - TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
pramipexole dihydrochloride(UNII: 3D867NP06J) (pramipexole - UNII:83619PEU5T)	pramipexole dihydrochloride	0.250mg

Inactive Ingredients

Ingredient Name	Boehringer Ingelheim Pharmaceuticals, Inc.	Cardinal Health	Lake Erie Medical DBA Quality Care Products LLC
magnesium stearate(70097M6I30)
MANNITOL(3OWL53L36A)
POVIDONE(FZ989GH94E)
POVIDONES(FZ989GH94E)
silicon dioxide(ETJ7Z6XBU4)
starch, corn(O8232NY3SJ)

Drug Product Composition: Pramipexole Dihydrochloride