Deoxycholate Injection

Brand(s)
Kybella
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Kythera Biopharmaceuticals Inc. (2015-10-19)
Oldest Current Product
2015-06-08
License(s)
NDA
RxNORM
INJECTION\DEOXYCHOLATE
FDAOB
SUBCUTANEOUS\SOLUTION\DEOXYCHOLIC ACID
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\DEOXYCHOLIC ACID
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\DEOXYCHOLIC ACID

product(s) by strength(s)

2 ml deoxycholic acid 10 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1611680101KybellaNDAKythera Biopharmaceuticals Inc.2015-06-08DEOXYCHOLIC ACIDSUBCUTANEOUSINJECTION, SOLUTIONNDA206333fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA206333KYBELLAKYTHERA BIOPHARMACEUTICALS INC2015-04-29p7754230, METHOD FOR REDUCTION OF SUBMENTAL FAT
p8101593, SUBSTANCE
p8367649, SUBSTANCE
p8883770, SUBSTANCE
p8846066, METHOD FOR REDUCTION OF SUBMENTAL FAT
p8298556, METHOD FOR REDUCTION OF SUBMENTAL FAT
p8546367, METHOD FOR REDUCTION OF SUBMENTAL FAT, SUBSTANCE
p8653058, SUBSTANCE
p7622130, METHOD FOR REDUCTION OF SUBMENTAL FAT
p8461140, SUBSTANCE
p8242294
NDA206333_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206333_001RXDEOXYCHOLIC ACID (20MG/2ML)SUBCUTANEOUSSOLUTIONTrue2015-04-29KYBELLA

patent(s)

#idexpiration dateapplication(s)
1p7622130 (view patent)2027-12-10NDA206333
2p7754230 (view patent)2027-12-10NDA206333
3p8101593 (view patent)2030-03-02NDA206333
4p8242294 (view patent)2028-05-16NDA206333
5p8298556 (view patent)2025-08-03NDA206333
6p8367649 (view patent)2030-03-02NDA206333
7p8461140 (view patent)2028-02-21NDA206333
8p8546367 (view patent)2028-02-21NDA206333
9p8653058 (view patent)2030-03-02NDA206333
10p8846066 (view patent)2025-02-08NDA206333
11p8883770 (view patent)2028-02-21NDA206333

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553 (view SPL)These highlights do not include all the information needed to use KYBELLA safely and effectively. See full prescribing information for KYBELLA.KYBELLA (deoxycholic acid) injection, for subcutaneous useInitial U.S. Approval: 2015prescriptionHuman PrescriptionKythera Biopharmaceuticals Inc.2015-10-193611680101

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII