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FDA Approval

quinapril hydrochloride and hydrochlorothiazide

CompanyGreenstone LLC (DUNS: 825560733)

Effective Date

November 8, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Quinapril Hydrochloride(10 mg in 1 1)

Hydrochlorothiazide(12.5 mg in 1 1)

Registrants (1)

DUNS Number

113480771

Manufacturing Establishments (1)

Pfizer Manufacturing Deutschland GmbH

Labeler

Greenstone LLC

Registrant

Pfizer Inc

DUNS Number

341970073

Products (6)

quinapril hydrochloride and hydrochlorothiazide

NDC Product Code

59762-0222

Application Number

NDA020125

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

November 8, 2021

Ingredients

Quinapril HydrochlorideActive

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

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

quinapril and hydrochlorothiazide

NDC Product Code

59762-1112

Application Number

NDA020125

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

November 8, 2021

Ingredients

Quinapril HydrochlorideActive

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

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

quinapril hydrochloride and hydrochlorothiazide

NDC Product Code

59762-0223

Application Number

NDA020125

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

November 8, 2021

Ingredients

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

Quinapril HydrochlorideActive

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

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

quinapril and hydrochlorothiazide

NDC Product Code

59762-3212

Application Number

NDA020125

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

November 8, 2021

Ingredients

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Quinapril HydrochlorideActive

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

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

quinapril hydrochloride and hydrochlorothiazide

NDC Product Code

59762-0220

Application Number

NDA020125

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

November 8, 2021

Ingredients

Quinapril HydrochlorideActive

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

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

quinapril and hydrochlorothiazide

NDC Product Code

59762-5225

Application Number

NDA020125

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

November 8, 2021

Ingredients

Quinapril HydrochlorideActive

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

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

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