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FDA Approval

Pramipexole Dihydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Alembic Pharmaceuticals Limited

DUNS: 650574663

Effective Date

December 8, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Pramipexole(0.25 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Alembic Pharmaceuticals Limited

Labeler

Alembic Pharmaceuticals Limited

DUNS Number

650574671

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pramipexole Dihydrochloride

Product Details

NDC Product Code

46708-612

Application Number

ANDA078894

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2023

Ingredients

PramipexoleActive

Code: 3D867NP06JClass: ACTIBQuantity: 0.25 mg in 1 1

BETADEXInactive

Code: JV039JZZ3AClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Pramipexole Dihydrochloride

Product Details

NDC Product Code

46708-615

Application Number

ANDA078894

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2023

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

PramipexoleActive

Code: 3D867NP06JClass: ACTIBQuantity: 1.5 mg in 1 1

BETADEXInactive

Code: JV039JZZ3AClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Pramipexole Dihydrochloride

Product Details

NDC Product Code

46708-614

Application Number

ANDA078894

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2023

Ingredients

BETADEXInactive

Code: JV039JZZ3AClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

PramipexoleActive

Code: 3D867NP06JClass: ACTIBQuantity: 1 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

Pramipexole Dihydrochloride

Product Details

NDC Product Code

46708-611

Application Number

ANDA078894

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2023

Ingredients

PramipexoleActive

Code: 3D867NP06JClass: ACTIBQuantity: 0.125 mg in 1 1

BETADEXInactive

Code: JV039JZZ3AClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

Pramipexole Dihydrochloride

Product Details

NDC Product Code

46708-613

Application Number

ANDA078894

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2023

Ingredients

PramipexoleActive

Code: 3D867NP06JClass: ACTIBQuantity: 0.5 mg in 1 1

BETADEXInactive

Code: JV039JZZ3AClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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