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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 206333


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NDA 206333 describes KYBELLA, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the KYBELLA profile page.

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the deoxycholic acid profile page.
Summary for 206333
Tradename:KYBELLA
Applicant:Abbvie
Ingredient:deoxycholic acid
Patents:15
Formulation / Manufacturing:see details
Pharmacology for NDA: 206333
Physiological EffectDecreased Cell Membrane Integrity
Medical Subject Heading (MeSH) Categories for 206333
Suppliers and Packaging for NDA: 206333
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333 NDA Kythera Biopharmaceuticals Inc. 61168-101 61168-101-03 2 VIAL, GLASS in 1 CARTON (61168-101-03) / 2 mL in 1 VIAL, GLASS
KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333 NDA Kythera Biopharmaceuticals Inc. 61168-101 61168-101-04 4 VIAL, GLASS in 1 CARTON (61168-101-04) / 2 mL in 1 VIAL, GLASS (61168-101-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength20MG/2ML (10MG/ML)
Approval Date:Apr 29, 2015TE:APRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 2, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Dec 10, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR REDUCTION OF SUBMENTAL FAT
Patent:⤷  Try a TrialPatent Expiration:Dec 10, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR REDUCTION OF SUBMENTAL FAT

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