IGALMI
These highlights do not include all the information needed to use IGALMI safely and effectively. See full prescribing information for IGALMI. IGALMI™ (dexmedetomidine) sublingual film, for sublingual or buccal use Initial U.S. Approval: 1999
Approved
Approval ID
99476e8c-2527-4cb0-9d67-9f9cd91343c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2022
Manufacturers
FDA
BioXcel Therapeutics, Inc.
DUNS: 081102158
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DEXMEDETOMIDINE
PRODUCT DETAILS
NDC Product Code81092-1180
Application NumberNDA215390
Marketing CategoryC73594
Route of AdministrationSUBLINGUAL
Effective DateJuly 31, 2022
Generic NameDEXMEDETOMIDINE
INGREDIENTS (8)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
DEXMEDETOMIDINEActive
Quantity: 180 ug in 1 1
Code: 67VB76HONO
Classification: ACTIB
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
HYDROXYPROPYL CELLULOSE (430000 WAMW)Inactive
Code: VQ8ZWO78F6
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYDROXYPROPYL CELLULOSE (160000 WAMW)Inactive
Code: 0A7M0N7SPE
Classification: IACT
Peppermint OilInactive
Code: AV092KU4JH
Classification: IACT
DEXMEDETOMIDINE
PRODUCT DETAILS
NDC Product Code81092-1120
Application NumberNDA215390
Marketing CategoryC73594
Route of AdministrationSUBLINGUAL
Effective DateJuly 31, 2022
Generic NameDEXMEDETOMIDINE
INGREDIENTS (8)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
DEXMEDETOMIDINEActive
Quantity: 120 ug in 1 1
Code: 67VB76HONO
Classification: ACTIB
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
HYDROXYPROPYL CELLULOSE (160000 WAMW)Inactive
Code: 0A7M0N7SPE
Classification: IACT
Peppermint OilInactive
Code: AV092KU4JH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYDROXYPROPYL CELLULOSE (430000 WAMW)Inactive
Code: VQ8ZWO78F6
Classification: IACT