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FDA Product

TASCENSO ODT

Product approved by U.S. Food and Drug Administration (US)

Basic Information

TASCENSO ODT

70709-062

Regulatory Information

70709-062

NDA214962

C73594

January 24, 2023

USA

These highlights do not include all the information needed to use TASCENSO ODT™ safely and effectively. See full prescribing information for TASCENSO ODT. TASCENSO ODT (fingolimod) orally disintegrating tablets Initial U.S. Approval: 2010

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

218215530

Active Ingredients

Fingolimod Lauryl Sulfate

Quantity: 0.25 mg in 1 1

Code: J3HZQ9BE2S

Class Code: ACTIM

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

MEDIUM-CHAIN TRIGLYCERIDES

Code: C9H2L21V7U

Class Code: IACT

Sodium Chloride

Code: 451W47IQ8X

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

Active Moieties

Fingolimod

Code: 3QN8BYN5QF

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