Home Applications 213176 Application 213176
Type NDA
Sponsor TG THERAPEUTICS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 UKONIQ UMBRALISIB TOSYLATE TABLET;ORAL 200MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N213176-001 UKONIQ UMBRALISIB TOSYLATE EQ 200MG BASE TABLET / ORAL RLD 2021-02-05
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213176-001 10072013 2033-07-02 U-3063 2021-02-17 N213176-001 10072013 2033-07-02 U-3064 2021-02-17 N213176-001 10570142 2033-07-02 U-3063 Drug substance, Drug product 2021-02-17 N213176-001 10570142 2033-07-02 U-3064 Drug substance, Drug product 2021-02-17 N213176-001 10981919 2033-07-02 U-3063 2022-02-04 N213176-001 10981919 2033-07-02 U-3064 2022-02-04 N213176-001 9150579 2033-07-02 Drug substance, Drug product 2021-02-17 N213176-001 9669033 2033-07-02 U-3063 2021-02-17 N213176-001 9669033 2033-07-02 U-3064 2021-02-17 N213176-001 10414773 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 N213176-001 10414773 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 N213176-001 10947244 2035-05-26 U-3063 2021-04-07 N213176-001 10947244 2035-05-26 U-3064 2021-04-07 N213176-001 9969740 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 N213176-001 9969740 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213176-001 NCE 2026-02-05
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.
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 2026-09-14 22:38:34 2026-08 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD, RS 2021-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD, RS 2021-02-05 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD, RS 2021-02-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD, RS 2021-02-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD, RS 2021-02-05 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 14 · 536 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N213176-001 10072013 2033-07-02 U-3063 2021-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 10072013 2033-07-02 U-3064 2021-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 10570142 2033-07-02 U-3064 Drug substance, Drug product 2021-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 10570142 2033-07-02 U-3063 Drug substance, Drug product 2021-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 10981919 2033-07-02 U-3063 2022-02-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 10981919 2033-07-02 U-3064 2022-02-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 9150579 2033-07-02 Drug substance, Drug product 2021-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 9669033 2033-07-02 U-3063 2021-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 9669033 2033-07-02 U-3064 2021-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 10414773 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 10414773 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 10947244 2035-05-26 U-3063 2021-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 10947244 2035-05-26 U-3064 2021-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 9969740 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213176-001 9969740 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213176-001 10072013 2033-07-02 U-3063 2021-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 10072013 2033-07-02 U-3064 2021-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 10570142 2033-07-02 U-3064 Drug substance, Drug product 2021-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 10570142 2033-07-02 U-3063 Drug substance, Drug product 2021-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 10981919 2033-07-02 U-3063 2022-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 10981919 2033-07-02 U-3064 2022-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 9150579 2033-07-02 Drug substance, Drug product 2021-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 9669033 2033-07-02 U-3063 2021-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 9669033 2033-07-02 U-3064 2021-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 10414773 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 10414773 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 10947244 2035-05-26 U-3063 2021-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 10947244 2035-05-26 U-3064 2021-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 9969740 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213176-001 9969740 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213176-001 10072013 2033-07-02 U-3063 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10072013 2033-07-02 U-3064 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10570142 2033-07-02 U-3064 Drug substance, Drug product 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10570142 2033-07-02 U-3063 Drug substance, Drug product 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10981919 2033-07-02 U-3063 2022-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10981919 2033-07-02 U-3064 2022-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 9150579 2033-07-02 Drug substance, Drug product 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 9669033 2033-07-02 U-3063 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 9669033 2033-07-02 U-3064 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10414773 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 48 observed states.
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73150-200 UKONIQ umbralisib TG Therapeutics, Inc. NDA Current 73150-200 UKONIQ umbralisib TG Therapeutics, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 66562 ORIG 2021-03-05 66145 ORIG 2021-02-09 66144 ORIG 2021-02-09 66111 ORIG 2021-02-05 66110 ORIG 2021-02-05 66109 ORIG 2021-02-05