QUINAPRIL

Registrants (1)

Prinston Pharmaceutical Inc.

DUNS Number

967289799

Manufacturing Establishments (1)

Zhejiang Huahai Pharmaceutical Co. Ltd.

Labeler

Solco Healthcare US, LLC

Registrant

Prinston Pharmaceutical Inc.

DUNS Number

530732460

Products (4)

NDC Product Code

43547-412

Application Number

ANDA205823

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 26, 2020

Ingredients

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 20 mg in 1 1

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

QUINAPRIL

NDC Product Code

43547-413

Application Number

ANDA205823

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 26, 2020

Ingredients

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 40 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

QUINAPRIL

NDC Product Code

43547-410

Application Number

ANDA205823

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 26, 2020

Ingredients

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 5 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

QUINAPRIL

NDC Product Code

43547-411

Application Number

ANDA205823

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 26, 2020

Ingredients

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 10 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

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QUINAPRIL

Registrants (1)

Manufacturing Establishments (1)

Products (4)

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