FROVA

Manufacturing Establishments (1)

Labeler

STAT RX USA LLC

DUNS Number

786036330

NDC Product Code

16590-396

Application Number

NDA021006

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

June 18, 2010

Ingredients

Code: D28J6W18HYClass: ACTIBQuantity: 2.5 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

LACTOSEInactive

Code: J2B2A4N98GClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

HYPROMELLOSEInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT