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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

Zydus Lifesciences Limited

DUNS: 918596198

Effective Date

December 16, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pramipexole(0.25 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Zydus Lifesciences Limited

DUNS Number

918596198

Manufacturing Establishments1

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

Zydus Lifesciences Limited

Labeler

Zydus Lifesciences Limited

Registrant

Zydus Lifesciences Limited

DUNS Number

918596198

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

65841-735

Application Number

ANDA078920

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 16, 2022

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

PramipexoleActive

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

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

PRAMIPEXOLE DIHYDROCHLORIDE

Product Details

NDC Product Code

65841-738

Application Number

ANDA078920

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 16, 2022

Ingredients

PramipexoleActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

PRAMIPEXOLE DIHYDROCHLORIDE

Product Details

NDC Product Code

65841-844

Application Number

ANDA078920

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 16, 2022

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

PramipexoleActive

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

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

PRAMIPEXOLE DIHYDROCHLORIDE

Product Details

NDC Product Code

65841-734

Application Number

ANDA078920

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 16, 2022

Ingredients

D&C RED NO. 27Inactive

Code: 2LRS185U6KClass: IACT

PramipexoleActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

PRAMIPEXOLE DIHYDROCHLORIDE

Product Details

NDC Product Code

65841-737

Application Number

ANDA078920

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 16, 2022

Ingredients

PramipexoleActive

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

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

PRAMIPEXOLE DIHYDROCHLORIDE

Product Details

NDC Product Code

65841-736

Application Number

ANDA078920

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 16, 2022

Ingredients

PramipexoleActive

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

D&C RED NO. 27Inactive

Code: 2LRS185U6KClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

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