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 1.

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
2026-08-01 22:54:32	2026-06	N213176-001	UKONIQ	EQ 200MG BASE	TABLET / ORAL		RLD	2021-02-05	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N213176-001	10072013	2033-07-02	U-3063		2021-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	10072013	2033-07-02	U-3064		2021-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	10570142	2033-07-02	U-3064	Drug substance, Drug product	2021-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	10570142	2033-07-02	U-3063	Drug substance, Drug product	2021-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	10981919	2033-07-02	U-3063		2022-02-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	10981919	2033-07-02	U-3064		2022-02-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	9150579	2033-07-02		Drug substance, Drug product	2021-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	9669033	2033-07-02	U-3063		2021-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	9669033	2033-07-02	U-3064		2021-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	10414773	2035-05-26	U-3063	Drug substance, Drug product	2021-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	10414773	2035-05-26	U-3064	Drug substance, Drug product	2021-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	10947244	2035-05-26	U-3063		2021-04-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	10947244	2035-05-26	U-3064		2021-04-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	9969740	2035-05-26	U-3064	Drug substance, Drug product	2021-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N213176-001	9969740	2035-05-26	U-3063	Drug substance, Drug product	2021-02-17	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N213176-001	NCE	2026-02-05	`a50c72e98297…`

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