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Details for New Drug Application (NDA): 206333

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NDA 206333 describes KYBELLA, which is a drug marketed by Kythera Biopharms and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the KYBELLA profile page.

The generic ingredient in KYBELLA is deoxycholic acid. There are twenty-nine 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 NDA: 206333

Tradename:
KYBELLA
Applicant:
Kythera Biopharms
Ingredient:
deoxycholic acid
Patents:11
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 61168-101-04 4 VIAL, GLASS in 1 CARTON (61168-101-04) > 2 mL in 1 VIAL, GLASS (61168-101-01)
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS 206333 NDA Kythera Biopharmaceuticals Inc. 61168-101 61168-101-94 4 VIAL, GLASS in 1 CARTON (61168-101-94) > 2 mL in 1 VIAL, GLASS (61168-101-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength20MG/2ML (10MG/ML)
Approval Date:Apr 29, 2015TE:RLD:Yes
Patent:8,101,593Patent Expiration:Mar 2, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:8,242,294Patent Expiration:May 16, 2028Product Flag?Substance Flag?YDelist Request?
Patent:8,367,649Patent Expiration:Mar 2, 2030Product Flag?YSubstance Flag?Delist Request?


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