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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

ScieGen Pharmaceuticals Inc

DUNS: 079391286

Effective Date

January 7, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pramipexole(0.75 mg in 1 1)

Manufacturing Establishments1

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

ScieGen Pharmaceuticals Inc

Labeler

ScieGen Pharmaceuticals Inc

DUNS Number

079391286

Products6

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

50228-129

Application Number

ANDA203855

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 7, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

PramipexoleActive

Code: 3D867NP06JClass: ACTIBQuantity: 0.75 mg in 1 1

Pramipexole Dihydrochloride

Product Details

NDC Product Code

50228-126

Application Number

ANDA203855

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 7, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

PramipexoleActive

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

Pramipexole Dihydrochloride

Product Details

NDC Product Code

50228-128

Application Number

ANDA203855

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 7, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

PramipexoleActive

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

Pramipexole Dihydrochloride

Product Details

NDC Product Code

50228-131

Application Number

ANDA203855

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 7, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

PramipexoleActive

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

Pramipexole Dihydrochloride

Product Details

NDC Product Code

50228-130

Application Number

ANDA203855

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 7, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

PramipexoleActive

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

Pramipexole Dihydrochloride

Product Details

NDC Product Code

50228-127

Application Number

ANDA203855

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 7, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

PramipexoleActive

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

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

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