Application 206333

Type
NDA
Sponsor
KYTHERA BIOPHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KYBELLADEOXYCHOLIC ACIDSOLUTION;SUBCUTANEOUS20MG/2ML (10MG/ML)YesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206333-001KYBELLADEOXYCHOLIC ACID20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N206333-001AP

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206333-00176221302027-12-10U-16902015-05-07
N206333-00177542302027-12-10U-16902015-05-07
N206333-00184611402028-02-21Drug product2015-05-07
N206333-00185463672028-02-21U-1690Drug product2015-05-27
N206333-00188837702028-02-21Drug product2015-05-27
N206333-00195221552028-02-21U-1940Drug product2017-01-19
N206333-00196363492028-02-21U-19402017-08-29
N206333-00199499862028-02-21U-19402018-05-24
N206333-00182422942028-05-16Drug substance2015-05-07
N206333-001105002142030-03-02Drug product2020-01-22
N206333-00181015932030-03-02Drug product2015-05-07
N206333-00183676492030-03-02Drug product2015-05-07
N206333-00186530582030-03-02Drug product2015-05-07
N206333-001121616532032-02-17U-19402025-01-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2015-04-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2015-04-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2015-04-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2015-04-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2015-04-293f01610625f2…
2019-09-15 20:21 UTC2019-09N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2015-04-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2015-04-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206333-001KYBELLA20MG/2ML (10MG/ML)SOLUTION / SUBCUTANEOUSAPRLD, RS2015-04-29e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N206333-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206333-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N206333-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206333-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206333-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206333-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206333-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206333-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206333-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206333-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206333-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206333-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206333-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206333-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206333-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206333-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206333-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N206333-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206333-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206333-001AP187673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206333-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206333-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206333-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206333-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206333-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206333-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206333-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N206333-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N206333-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206333-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206333-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206333-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N206333-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206333-001AP1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 16 · 627 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N206333-00176221302027-12-10U-16902015-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-00177542302027-12-10U-16902015-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-00184611402028-02-21Drug product2015-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-00185463672028-02-21U-1690Drug product2015-05-27caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-00188837702028-02-21Drug product2015-05-27caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-00195221552028-02-21U-1940Drug product2017-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-00196363492028-02-21U-19402017-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-00199499862028-02-21U-19402018-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-00182422942028-05-16Drug substance2015-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-001105002142030-03-02Drug product2020-01-22caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-00181015932030-03-02Drug product2015-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-00183676492030-03-02Drug product2015-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-00186530582030-03-02Drug product2015-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N206333-001121616532032-02-17U-19402025-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206333-00176221302027-12-10U-16902015-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-00177542302027-12-10U-16902015-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-00184611402028-02-21Drug product2015-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-00185463672028-02-21U-1690Drug product2015-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-00188837702028-02-21Drug product2015-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-00195221552028-02-21U-1940Drug product2017-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-00196363492028-02-21U-19402017-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-00199499862028-02-21U-19402018-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-00182422942028-05-16Drug substance2015-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-001105002142030-03-02Drug product2020-01-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-00181015932030-03-02Drug product2015-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-00183676492030-03-02Drug product2015-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-00186530582030-03-02Drug product2015-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206333-001121616532032-02-17U-19402025-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-00188460662025-02-08U-16902015-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-00182985562025-08-03U-16902015-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-00176221302027-12-10U-16902015-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-00177542302027-12-10U-16902015-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-00184611402028-02-21Drug product2015-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-00185463672028-02-21U-1690Drug product2015-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-00188837702028-02-21Drug product2015-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-00195221552028-02-21U-1940Drug product2017-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-00196363492028-02-21U-19402017-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-00199499862028-02-21U-19402018-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-00182422942028-05-16Drug substance2015-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206333-001105002142030-03-02Drug product2020-01-2231067a03dcf5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KYBELLADEOXYCHOLIC ACIDKythera Biopharmaceuticals Inc.fe431ed4-ea6f-4e99-b4bc-ec25ae7b85532024-10-30Warnings, Adverse reactionsExact 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61168-101KYBELLADeoxycholic AcidKythera Biopharmaceuticals Inc.NDACurrent
61168-101KYBELLADeoxycholic AcidKythera Biopharmaceuticals Inc.NDACurrent
61168-101KYBELLADeoxycholic AcidKythera Biopharmaceuticals Inc.NDACurrent
61168-101KYBELLADeoxycholic AcidKythera Biopharmaceuticals Inc.NDACurrent
61168-101KYBELLADeoxycholic AcidKythera Biopharmaceuticals Inc.NDACurrent
61168-101KYBELLADeoxycholic AcidKythera Biopharmaceuticals Inc.NDACurrent
61168-101KYBELLADeoxycholic AcidKythera Biopharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72262SUPPL2022-10-07
72257SUPPL2022-10-06
63260SUPPL2020-05-22
63259SUPPL2020-05-22
63206SUPPL2020-05-21
63203SUPPL2020-05-21
51867SUPPL2018-01-26
51087SUPPL2018-01-18
43518ORIG2015-05-28
24513ORIG2015-05-28
40539ORIG2015-04-29
32798ORIG2015-04-29