Application 079157

Type: ANDA
Sponsor: PHARMALUCENCE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TECHNETIUM TC 99M SESTAMIBI	TECHNETIUM TC-99M SESTAMIBI KIT	INJECTABLE;INJECTION	10-30mCi	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
A079157-001	TECHNETIUM TC 99M SESTAMIBI	TECHNETIUM TC-99M SESTAMIBI KIT	10-30mCi	INJECTABLE / INJECTION			2009-07-10

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	Product TE source text	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A079157-001	TECHNETIUM TC 99M SESTAMIBI	10-30mCi	INJECTABLE / INJECTION	AP	2009-07-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079157-001	TECHNETIUM TC 99M SESTAMIBI	10-30mCi	INJECTABLE / INJECTION	AP	2009-07-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079157-001	TECHNETIUM TC 99M SESTAMIBI	10-30mCi	INJECTABLE / INJECTION	AP	2009-07-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A079157-001	TECHNETIUM TC 99M SESTAMIBI	10-30mCi	INJECTABLE / INJECTION		2009-07-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079157-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079157-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079157-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079157-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079157-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079157-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079157-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079157-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079157-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079157-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079157-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079157-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079157-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079157-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079157-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079157-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079157-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079157-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079157-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079157-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079157-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079157-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079157-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079157-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079157-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079157-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079157-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079157-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079157-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079157-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079157-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079157-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079157-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079157-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079157-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079157-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079157-001	AP	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Technetium Tc 99m Sestamibi	TECHNETIUM TC 99M SESTAMIBI	Curium US LLC	4110d0f4-3bcf-4688-a39f-42a81064c796	2022-05-19	Warnings, Adverse reactions	Name fallback brand name: Technetium Tc 99m Sestamibi
TECHNETIUM TC 99M SESTAMIBI	TECHNETIUM TC 99M SESTAMIBI	Jubilant Draximage (USA) Inc.	07c893fc-cfba-1d98-0232-6448463afb87	2021-10-22	Warnings, Adverse reactions	Name fallback brand name: TECHNETIUM TC 99M SESTAMIBI

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45567-0555	Kit for the Preparation of Technetium Tc99m Sestamibi	TECHNETIUM TC-99M SESTAMIBI	Pharmalucence, Inc.	ANDA	Current
45567-0555	Kit for the Preparation of Technetium Tc99m Sestamibi	TECHNETIUM TC-99M SESTAMIBI	Sun Pharmaceutical Industries, Inc.	ANDA	Current
45567-0555	Kit for the Preparation of Technetium Tc99m Sestamibi	TECHNETIUM TC-99M SESTAMIBI	Pharmalucence, Inc.	ANDA	Current
45567-0555	Kit for the Preparation of Technetium Tc99m Sestamibi	TECHNETIUM TC-99M SESTAMIBI	Sun Pharmaceutical Industries, Inc.	ANDA	Current
45567-0555	Kit for the Preparation of Technetium Tc99m Sestamibi	TECHNETIUM TC-99M SESTAMIBI	Pharmalucence, Inc.	ANDA	Current