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FDA Approval

ropinirole hydrochloride

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

FDA Approval Summary

Company

DUNS: 832926666

Effective Date

August 19, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ropinirole(1 mg in 1 1)

Products4

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

ropinirole hydrochloride

Product Details

NDC Product Code

50268-743

Application Number

ANDA078110

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 19, 2022

Ingredients

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

RopiniroleActive

Code: D7ZD41RZI9Class: ACTIMQuantity: 1 mg in 1 1

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

ropinirole hydrochloride

Product Details

NDC Product Code

50268-741

Application Number

ANDA078110

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 19, 2022

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

RopiniroleActive

Code: D7ZD41RZI9Class: ACTIMQuantity: 0.25 mg in 1 1

ropinirole hydrochloride

Product Details

NDC Product Code

50268-742

Application Number

ANDA078110

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 19, 2022

Ingredients

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

RopiniroleActive

Code: D7ZD41RZI9Class: ACTIMQuantity: 0.5 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ropinirole hydrochloride

Product Details

NDC Product Code

50268-744

Application Number

ANDA078110

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 19, 2022

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62Class: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

RopiniroleActive

Code: D7ZD41RZI9Class: ACTIMQuantity: 2 mg in 1 1

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