LOCAMETZ

Product NDC: 69488-017
Requested package NDC: 69488-017-61
11-digit product format: 694880017
Labeler code: 69488
Product ID: 69488-017_1ea62b65-8138-4a88-8a33-4060ececa42f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: kit for the preparation of gallium Ga 68 gozetotide
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Advanced Accelerator Applications USA, Inc
Application: NDA215841
Marketing category: NDA
Marketing start: 2022-03-23
Marketing end: 0000-00-00
Substance: GOZETOTIDE
Active strength: 25 ug/1
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69488-017	69488-017-61	D	Discontinued by firm		2026-10-02

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
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
2026-09-14 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 1 of 2 · 41 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	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215841-001	12109277	2036-03-09	U-4002		2024-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215841-001	11369590	2028-08-15	U-3400	Drug substance, Drug product	2022-07-28	`f41ea6bd6efb…`
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…`

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
992a1833-9957-43c6-9b91-c0feb8613f61	Product name	1	20260107
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69488-017-61	LOCAMETZ	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		9
69488-017-61	LOCAMETZ	1 in 1 VIAL, MULTI-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69488-017-61	EA - Each	69488-017	003ebd2f-d6b5-4779-956e-635c55ff65c6	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69488-017	LOCAMETZ (KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ADVANCED ACCELERATOR APPLICATIONS USA, INC]	7	Legacy NDC, 2 package rows	20250406_1ea62b65-8138-4a88-8a33-4060ececa42f.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69488-017-61	69488001761	1 VIAL, MULTI-DOSE in 1 CARTON (69488-017-61) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE	2022-03-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOCAMETZ	Advanced Accelerator Applications USA, Inc \| Novartis Pharmaceuticals Corporation	2025-12-15	HUMAN PRESCRIPTION DRUG LABEL	9