MedPath
FDA Approval

Quinapril

October 10, 2015

HUMAN PRESCRIPTION DRUG LABEL

Registrants (1)

Camber Pharmaceuticals, Inc.

826774775

Manufacturing Establishments (1)

InvaGen Pharmaceuticals, Inc.

Camber Pharmaceuticals, Inc.

Camber Pharmaceuticals, Inc.

165104469

Products (4)

Quinapril

31722-270

ANDA078457

ANDA (C73584)

ORAL

October 10, 2015

Code: 33067B3N2MClass: ACTIRQuantity: 40 mg in 1 1
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT

Quinapril

31722-269

ANDA078457

ANDA (C73584)

ORAL

October 10, 2015

POVIDONEInactive
Code: FZ989GH94EClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
Code: 33067B3N2MClass: ACTIRQuantity: 20 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT

Quinapril

31722-268

ANDA078457

ANDA (C73584)

ORAL

October 10, 2015

Code: 33067B3N2MClass: ACTIRQuantity: 10 mg in 1 1
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT

Quinapril

31722-267

ANDA078457

ANDA (C73584)

ORAL

October 10, 2015

FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
Code: 33067B3N2MClass: ACTIRQuantity: 5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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