Quinapril

Registrants (1)

Cipla USA Inc.

DUNS Number

078719707

Manufacturing Establishments (1)

InvaGen Pharmaceutical Inc

Labeler

Cipla USA Inc.

Registrant

Cipla USA Inc.

DUNS Number

080334903

Products (4)

NDC Product Code

69097-843

Application Number

ANDA078457

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 13, 2019

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

Quinapril HydrochlorideActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

Quinapril

NDC Product Code

69097-842

Application Number

ANDA078457

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 13, 2019

Ingredients

Quinapril HydrochlorideActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

Quinapril

NDC Product Code

69097-839

Application Number

ANDA078457

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 13, 2019

Ingredients

Quinapril HydrochlorideActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

Quinapril

NDC Product Code

69097-841

Application Number

ANDA078457

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 13, 2019

Ingredients

Quinapril HydrochlorideActive

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

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

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Quinapril

Registrants (1)

Manufacturing Establishments (1)

Products (4)

Quinapril

Quinapril

Quinapril

Quinapril