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.
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 |
Pharmacology for NDA: 206333
| Physiological Effect | Decreased 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: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 20MG/2ML (10MG/ML) | ||||
| Approval Date: | Apr 29, 2015 | TE: | AP | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 2, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 10, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR REDUCTION OF SUBMENTAL FAT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 10, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR REDUCTION OF SUBMENTAL FAT | ||||||||
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