ZONTIVITY

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

DUNS Number

985620239

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

70347-208

Application Number

NDA204886

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

April 8, 2021

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

Code: IN66038E6CClass: ACTIMQuantity: 2.08 mg in 1 1

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0WClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT