Application 019829

Type: NDA
Sponsor: GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CERETEC	TECHNETIUM TC-99M EXAMETAZIME KIT	INJECTABLE;INJECTION	N/A	Yes	Yes

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
N019829-001	CERETEC	TECHNETIUM TC-99M EXAMETAZIME KIT	N/A	INJECTABLE / INJECTION		RLD, RS	1988-12-30

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 1 of 2 · 42 observed 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	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceretec	TECHNETIUM TC-99M EXAMETAZIME AND COBALTOUS CHLORIDE	Medi-Physics, Inc. dba GE Healthcare	d9c291e0-cd0d-43d2-87b4-defefd531942	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019829 application number: NDA019829 ndc (product): 17156-025
CERETEC	TECHNETIUM TC-99M EXAMETAZIME	Medi-Physics Inc. dba GE Healthcare.	3c1eca7e-57a0-4876-8ed6-cd655ef5e296	2024-01-10	Adverse reactions	Exact identifier application applno (NDA): 019829 application number: NDA019829 ndc (product): 17156-022

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
17156-022	CERETEC	TECHNETIUM TC-99M EXAMETAZIME	Medi-Physics Inc. dba GE Healthcare.	NDA	Current
17156-023	Ceretec	Exametazime	Medi-Physics Inc.	NDA	Current
17156-025	Ceretec	Technetium Tc-99m Exametazime and Cobaltous Chloride	Medi-Physics, Inc. dba GE Healthcare	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55735	SUPPL	2018-10-01
55535	SUPPL	2018-09-20
1657	SUPPL	2013-08-06
33995	SUPPL	2013-08-05
19270	SUPPL	2005-06-21