Application 019928

Type: NDA
Sponsor: BRACCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDIOTEC	TECHNETIUM TC-99M TEBOROXIME KIT	INJECTABLE;INJECTION	N/A	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
N019928-001	CARDIOTEC	TECHNETIUM TC-99M TEBOROXIME KIT	N/A	INJECTABLE / INJECTION			1990-12-19

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N019928-001	CARDIOTEC	N/A	INJECTABLE / INJECTION	1990-12-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019928-001	CARDIOTEC	N/A	INJECTABLE / INJECTION	1990-12-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019928-001	CARDIOTEC	N/A	INJECTABLE / INJECTION	1990-12-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019928-001	CARDIOTEC	N/A	INJECTABLE / INJECTION	1990-12-19	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019928-001	6056941	2019-07-28	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N019928-001	6056941	2019-07-28	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019928-001	6056941	2019-07-28	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019928-001	6056941	2019-07-28	Drug product	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
20425	SUPPL	2012-01-27
1815	SUPPL	2003-05-29