PRAMIPEXOLE DIHYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg Tablets
Approved
Approval ID
04bf2b80-5371-4641-bbf5-e19587c0e9cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 17, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PRAMIPEXOLE DIHYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-409
Application NumberANDA077724
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2010
FDA Product Classification
INGREDIENTS (4)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB