APRISO

Manufacturing Establishments (1)

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

NDC Product Code

54868-6150

Application Number

NDA022301

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

February 15, 2012

Ingredients

Code: 4Q81I59GXCClass: ACTIBQuantity: 375 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

ASPARTAMEInactive

Code: Z0H242BBR1Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT