Details for New Drug Application (NDA): 206333
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The generic ingredient in KYBELLA is deoxycholic acid. There is one drug master file entry 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: | 14 |
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: | 10,500,214 | Patent Expiration: | Mar 2, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 12,161,653 | Patent Expiration: | Feb 17, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING | ||||||||
| Patent: | 7,622,130 | Patent Expiration: | Dec 10, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR REDUCTION OF SUBMENTAL FAT | ||||||||
Expired US Patents for NDA 206333
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | KYBELLA | deoxycholic acid | SOLUTION;SUBCUTANEOUS | 206333-001 | Apr 29, 2015 | 8,298,556 | ⤷ Start Trial |
| Abbvie | KYBELLA | deoxycholic acid | SOLUTION;SUBCUTANEOUS | 206333-001 | Apr 29, 2015 | 8,846,066 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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