Asenapine

Basic Information

Product Name

Asenapine

FDA Product Code

59762-2012

Regulatory Information

NDC Product Code

59762-2012

Application Number

NDA022117

Marketing Category

C73605

Effective Date

October 18, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use asenapine sublingual tablets safely and effectively. See full prescribing information for asenapine . asenapine sublingual tablets Initial U.S. Approval: 2009

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ASENAPINE MALEATE

Quantity: 5 mg in 1 1

Code: CU9463U2E2

Class Code: ACTIM

GELATIN

Code: 2G86QN327L

Class Code: IACT

SUCRALOSE

Code: 96K6UQ3ZD4

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

Active Moieties

Code: JKZ19V908O

Asenapine

Basic Information

Regulatory Information

Company Information

Active Ingredients

GELATIN

SUCRALOSE

MANNITOL

Active Moieties

ASENAPINE