Application 214032

Type: NDA
Sponsor: TELIX PHARMACEUTICALS US INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ILLUCCIX	GOZETOTIDE;D-MANNOSE	INJECTABLE;INJECTION	25MCG;10MCG	No	No

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
N214032-001	ILLUCCIX	GALLIUM GA-68 GOZETOTIDE	N/A	POWDER / INTRAVENOUS		RLD, RS	2021-12-17

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214032-001	11027031	2035-07-28	U-3317		2022-03-04

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214032-001	ILLUCCIX	6.7mCi/ML	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214032-001	ILLUCCIX	6.7mCi/ML	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214032-001	ILLUCCIX	N/A	POWDER / INTRAVENOUS	RLD, RS	2021-12-17	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214032-001	11027031	2035-07-28	U-3317	2022-03-04	`a50c72e98297…`

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
ILLUCCIX	KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION	Telix Pharmaceuticals (US) Inc.	d4643b31-9b4f-673f-e053-2a95a90a559d	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214032 application number: NDA214032 ndc (product): 74725-100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
74725-100	ILLUCCIX	Kit for the preparation of gallium Ga 68 gozetotide injection	Telix Pharmaceuticals US Inc.	NDA	Current
74725-100	ILLUCCIX	Kit for the preparation of gallium Ga 68 gozetotide injection	Telix Pharmaceuticals US Inc.	NDA	Current
74725-100	ILLUCCIX	Kit for the preparation of gallium Ga 68 gozetotide injection	Telix Pharmaceuticals US Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84418	SUPPL	2025-12-15
84365	SUPPL	2025-12-09
83346	SUPPL	2025-09-12
83344	SUPPL	2025-09-12
73784	SUPPL	2023-03-17
73776	SUPPL	2023-03-16
71699	ORIG	2022-08-03
69722	ORIG	2021-12-21