Application 017478

Type: NDA
Sponsor: LANTHEUS MEDCL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GALLIUM CITRATE GA 67	GALLIUM CITRATE GA-67	INJECTABLE;INJECTION	2mCi/ML	No	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
N017478-001	GALLIUM CITRATE GA 67	GALLIUM CITRATE GA-67	2mCi/ML	INJECTABLE / INJECTION		Approved before 1982

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N017478-001	GALLIUM CITRATE GA 67	2mCi/ML	INJECTABLE / INJECTION	BS	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017478-001	GALLIUM CITRATE GA 67	2mCi/ML	INJECTABLE / INJECTION	BS	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017478-001	GALLIUM CITRATE GA 67	2mCi/ML	INJECTABLE / INJECTION		Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017478-001	BS	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017478-001	BS	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017478-001	BS	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017478-001	BS	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017478-001	BS	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017478-001	BS	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017478-001	BS	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017478-001	BS	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017478-001	BS	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017478-001	BS	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017478-001	BS	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017478-001	BS	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017478-001	BS	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017478-001	BS	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017478-001	BS	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017478-001	BS	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017478-001	BS	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017478-001	BS	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017478-001	BS	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017478-001	BS	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017478-001	BS	1	`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
GALLIUM CITRATE GA-67	GALLIUM CITRATE GA-67	Curium US LLC	5f670c12-cca5-4d73-8a88-241f753d1bc7	2025-08-13	Warnings, Adverse reactions	Name fallback generic name: GALLIUM CITRATE GA-67

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11994-121	Gallium	GALLIUM CITRATE GA-67	Lantheus Medical Imaging, Inc.	NDA	Current
11994-121	Gallium	GALLIUM CITRATE GA-67	Lantheus Medical Imaging, Inc.	NDA	Current
11994-121	Gallium	GALLIUM CITRATE GA-67	Lantheus Medical Imaging, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55131	SUPPL	2018-08-07
55123	SUPPL	2018-08-07
600	SUPPL	2011-10-26
11001	SUPPL	2011-10-25
13154	SUPPL	2004-03-10