Application 215841

Type: NDA
Sponsor: ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOCAMETZ KIT	GALLIUM GA 68 GOZETOTIDE	POWDER;INTRAVENOUS	37MCI/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N215841-001	LOCAMETZ	GALLIUM GA-68 GOZETOTIDE	N/A	POWDER / INTRAVENOUS		RLD, RS	2022-03-23

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28
N215841-001	12109277	2036-03-09	U-4002		2024-10-08

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
2026-10-15 13:18:30	2026-09	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215841-001	LOCAMETZ	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-03-23	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215841-001	NP	2025-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215841-001	NP	2025-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215841-001	NP	2025-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215841-001	NP	2025-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215841-001	NP	2025-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215841-001	NP	2025-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215841-001	NP	2025-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215841-001	NP	2025-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215841-001	NP	2025-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215841-001	NP	2025-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215841-001	NP	2025-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215841-001	NP	2025-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215841-001	NP	2025-03-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215841-001	NP	2025-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215841-001	NP	2025-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215841-001	NP	2025-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215841-001	NP	2025-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215841-001	NP	2025-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215841-001	NP	2025-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215841-001	NP	2025-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215841-001	NP	2025-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215841-001	NP	2025-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215841-001	NP	2025-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215841-001	NP	2025-03-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215841-001	NP	2025-03-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215841-001	NP	2025-03-23	`cb3db0bc1861…`

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
LOCAMETZ	KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE	Novartis Pharmaceuticals Corporation	8683b06e-4901-4526-89ad-23a8fe2d1331	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215841 application number: NDA215841

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69488-017	LOCAMETZ	kit for the preparation of gallium Ga 68 gozetotide	Advanced Accelerator Applications USA, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81898	SUPPL	2025-04-09
81779	SUPPL	2025-03-31
71293	ORIG	2022-06-14
71200	ORIG	2022-06-02
70597	ORIG	2022-03-24