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Pramipexole Dihydrochloride

These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997

Approved
Approval ID

1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 16, 2021

Manufacturers
FDA

Xiamen LP Pharmaceutical Co., Ltd.

DUNS: 544415908

Products 2

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 Code71034-003
Application NumberANDA212797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 16, 2021
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CARBOMER HOMOPOLYMER TYPE AInactive
Code: F68VH75CJC
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.75 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT

Pramipexole Dihydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71034-002
Application NumberANDA212797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 16, 2021
FDA Product Classification

INGREDIENTS (6)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBOMER HOMOPOLYMER TYPE AInactive
Code: F68VH75CJC
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.375 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB

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Pramipexole Dihydrochloride - FDA Drug Approval Details