Atelvia

Products1

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

NDC Product Code

0430-0979

Application Number

NDA022560

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 27, 2023

Ingredients

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8JClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM STARCH GLYCOLATE TYPE AInactive

Code: H8AV0SQX4DClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Code: HU2YAQ274OClass: ACTIRQuantity: 30.1 mg in 1 1

Code: F67L43UT5CClass: ACTIRQuantity: 4.9 mg in 1 1