Home Applications 206333 Application 206333
Type NDA
Sponsor KYTHERA BIOPHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KYBELLA DEOXYCHOLIC ACID SOLUTION;SUBCUTANEOUS 20MG/2ML (10MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206333-001 KYBELLA DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N206333-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206333-001 7622130 2027-12-10 U-1690 2015-05-07 N206333-001 7754230 2027-12-10 U-1690 2015-05-07 N206333-001 8461140 2028-02-21 Drug product 2015-05-07 N206333-001 8546367 2028-02-21 U-1690 Drug product 2015-05-27 N206333-001 8883770 2028-02-21 Drug product 2015-05-27 N206333-001 9522155 2028-02-21 U-1940 Drug product 2017-01-19 N206333-001 9636349 2028-02-21 U-1940 2017-08-29 N206333-001 9949986 2028-02-21 U-1940 2018-05-24 N206333-001 8242294 2028-05-16 Drug substance 2015-05-07 N206333-001 10500214 2030-03-02 Drug product 2020-01-22 N206333-001 8101593 2030-03-02 Drug product 2015-05-07 N206333-001 8367649 2030-03-02 Drug product 2015-05-07 N206333-001 8653058 2030-03-02 Drug product 2015-05-07 N206333-001 12161653 2032-02-17 U-1940 2025-01-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2015-04-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2015-04-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2015-04-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2015-04-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2015-04-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2015-04-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2015-04-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 3a93d1ddd44b…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 17 · 655 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N206333-001 7622130 2027-12-10 U-1690 2015-05-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 7754230 2027-12-10 U-1690 2015-05-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 8461140 2028-02-21 Drug product 2015-05-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 8546367 2028-02-21 U-1690 Drug product 2015-05-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 8883770 2028-02-21 Drug product 2015-05-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 9522155 2028-02-21 U-1940 Drug product 2017-01-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 9636349 2028-02-21 U-1940 2017-08-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 9949986 2028-02-21 U-1940 2018-05-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 8242294 2028-05-16 Drug substance 2015-05-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 10500214 2030-03-02 Drug product 2020-01-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 8101593 2030-03-02 Drug product 2015-05-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 8367649 2030-03-02 Drug product 2015-05-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 8653058 2030-03-02 Drug product 2015-05-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206333-001 12161653 2032-02-17 U-1940 2025-01-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 N206333-001 7622130 2027-12-10 U-1690 2015-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 7754230 2027-12-10 U-1690 2015-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 8461140 2028-02-21 Drug product 2015-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 8546367 2028-02-21 U-1690 Drug product 2015-05-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 8883770 2028-02-21 Drug product 2015-05-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 9522155 2028-02-21 U-1940 Drug product 2017-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 9636349 2028-02-21 U-1940 2017-08-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 9949986 2028-02-21 U-1940 2018-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 8242294 2028-05-16 Drug substance 2015-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 10500214 2030-03-02 Drug product 2020-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 8101593 2030-03-02 Drug product 2015-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 8367649 2030-03-02 Drug product 2015-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 8653058 2030-03-02 Drug product 2015-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206333-001 12161653 2032-02-17 U-1940 2025-01-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206333-001 7622130 2027-12-10 U-1690 2015-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 7754230 2027-12-10 U-1690 2015-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 8461140 2028-02-21 Drug product 2015-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 8546367 2028-02-21 U-1690 Drug product 2015-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 8883770 2028-02-21 Drug product 2015-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 9522155 2028-02-21 U-1940 Drug product 2017-01-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 9636349 2028-02-21 U-1940 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 9949986 2028-02-21 U-1940 2018-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 8242294 2028-05-16 Drug substance 2015-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 10500214 2030-03-02 Drug product 2020-01-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 8101593 2030-03-02 Drug product 2015-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 8367649 2030-03-02 Drug product 2015-05-07 caaa826d4ba7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61168-101 KYBELLA Deoxycholic Acid Kythera Biopharmaceuticals Inc. NDA Current 61168-101 KYBELLA Deoxycholic Acid Kythera Biopharmaceuticals Inc. NDA Current 61168-101 KYBELLA Deoxycholic Acid Kythera Biopharmaceuticals Inc. NDA Current 61168-101 KYBELLA Deoxycholic Acid Kythera Biopharmaceuticals Inc. NDA Current 61168-101 KYBELLA Deoxycholic Acid Kythera Biopharmaceuticals Inc. NDA Current 61168-101 KYBELLA Deoxycholic Acid Kythera Biopharmaceuticals Inc. NDA Current 61168-101 KYBELLA Deoxycholic Acid Kythera Biopharmaceuticals Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 72262 SUPPL 2022-10-07 72257 SUPPL 2022-10-06 63260 SUPPL 2020-05-22 63259 SUPPL 2020-05-22 63206 SUPPL 2020-05-21 63203 SUPPL 2020-05-21 51867 SUPPL 2018-01-26 51087 SUPPL 2018-01-18 43518 ORIG 2015-05-28 24513 ORIG 2015-05-28 40539 ORIG 2015-04-29 32798 ORIG 2015-04-29