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

Asenapine Maleate by

Drug Labeling and Warnings

Asenapine Maleate by is a Prescription medication manufactured, distributed, or labeled by Centaur Pharmaceuticals Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASENAPINE MALEATE - asenapine maleate tablet 
Centaur Pharmaceuticals Private Limited

----------

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image
ASENAPINE MALEATE 
asenapine maleate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 64330-625
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASENAPINE MALEATE (UNII: CU9463U2E2) (ASENAPINE - UNII:JKZ19V908O) ASENAPINE2.5 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize3mm
FlavorCHERRY (black cherry) Imprint Code B;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64330-625-0160 in 1 BOX; Type 0: Not a Combination Product12/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20596012/10/2020
Labeler - Centaur Pharmaceuticals Private Limited (918629361)
Registrant - Centaur Pharmaceuticals Private Limited (918629361)
Establishment
NameAddressID/FEIBusiness Operations
Centaur Pharmaceuticals Private Limited675596622MANUFACTURE(64330-625) , ANALYSIS(64330-625) , PACK(64330-625)

Revised: 12/2022
Document Id: 5ee49f6c-5284-410e-9c4e-174d285f7dc8
Set id: b4d3ae2a-eba5-478d-a350-c31634f7c041
Version: 2
Effective Time: 20221220
 
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.