Application 214993

Type: NDA
Sponsor: THERAGNOSTICS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEPHROSCAN	TECHNETIUM TC-99M SUCCIMER KIT	POWDER;INTRAVENOUS	N/A	Yes	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
N214993-001	NEPHROSCAN	TECHNETIUM TC-99M SUCCIMER	N/A	POWDER / INTRAVENOUS		RLD, RS	2022-02-18

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	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214993-001	NEPHROSCAN	N/A	POWDER / INTRAVENOUS	RLD, RS	2022-02-18	`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
NephroScan	SUCCIMER	Theragnostics Inc	ddd90c4a-5792-49c9-837f-710d1a604742	2024-09-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214993 application number: NDA214993 ndc (product): 71083-0020

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
71083-0020	NephroScan	SUCCIMER	Theragnostics Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73391	ORIG	2023-02-06
70224	ORIG	2022-02-22
70223	ORIG	2022-02-22