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 42 .
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 · 42 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 2026-08-18 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…2022-10-28 04:53 UTC 2022-10 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206333-001 KYBELLA 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2015-04-29 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 16 · 627 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2026-08-18 06:07:40 2026-07 N206333-001 8653058 2030-03-02 Drug product 2015-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206333-001 12161653 2032-02-17 U-1940 2025-01-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206333-001 7622130 2027-12-10 U-1690 2015-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 7754230 2027-12-10 U-1690 2015-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 8461140 2028-02-21 Drug product 2015-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 8546367 2028-02-21 U-1690 Drug product 2015-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 8883770 2028-02-21 Drug product 2015-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 9522155 2028-02-21 U-1940 Drug product 2017-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 9636349 2028-02-21 U-1940 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 9949986 2028-02-21 U-1940 2018-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 8242294 2028-05-16 Drug substance 2015-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 10500214 2030-03-02 Drug product 2020-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 8101593 2030-03-02 Drug product 2015-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 8367649 2030-03-02 Drug product 2015-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 8653058 2030-03-02 Drug product 2015-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206333-001 12161653 2032-02-17 U-1940 2025-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 8846066 2025-02-08 U-1690 2015-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 8298556 2025-08-03 U-1690 2015-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 7622130 2027-12-10 U-1690 2015-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 7754230 2027-12-10 U-1690 2015-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 8461140 2028-02-21 Drug product 2015-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 8546367 2028-02-21 U-1690 Drug product 2015-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 8883770 2028-02-21 Drug product 2015-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 9522155 2028-02-21 U-1940 Drug product 2017-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 9636349 2028-02-21 U-1940 2017-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 9949986 2028-02-21 U-1940 2018-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 8242294 2028-05-16 Drug substance 2015-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206333-001 10500214 2030-03-02 Drug product 2020-01-22 31067a03dcf5…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KYBELLA DEOXYCHOLIC ACID Kythera Biopharmaceuticals Inc. fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553 2024-10-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 206333 application number: NDA206333 ndc (product): 61168-101
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