SYMPROIC

SYMPROIC

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 016058955

Effective Date

December 23, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Naldemedine(0.2 mg in 1 1)

Products1

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

NDC Product Code

59385-041

Application Number

NDA208854

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 30, 2021

Ingredients

Code: V1N8F1RVVOClass: ACTIMQuantity: 0.2 mg in 1 1

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

MannitolInactive

Code: 3OWL53L36AClass: IACT

Croscarmellose SodiumInactive

Code: M28OL1HH48Class: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

TalcInactive

Code: 7SEV7J4R1UClass: IACT