FDA.reportPublic FDA data

Application 078098

Type
ANDA
Sponsor
CURIUM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TECHNETIUM TC 99M SESTAMIBITECHNETIUM TC-99M SESTAMIBI KITINJECTABLE;INJECTIONN/ANoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078098-001TECHNETIUM TC 99M SESTAMIBITECHNETIUM TC-99M SESTAMIBI KITN/AINJECTABLE / INJECTIONAP2008-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A078098-001AP

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-2284e616aacf4f…
2026-08-18 06:07:402026-07A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-223f01610625f2…
2019-09-15 20:21 UTC2019-09A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078098-001TECHNETIUM TC 99M SESTAMIBIN/AINJECTABLE / INJECTIONAP2008-09-22f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-09-29 23:25 UTC2022-09A078098-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078098-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078098-001AP1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Technetium Tc 99m SestamibiTECHNETIUM TC 99M SESTAMIBICurium US LLC4110d0f4-3bcf-4688-a39f-42a81064c7962022-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078098
application number: ANDA078098
ndc (product): 69945-092

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69945-092Technetium Tc 99m SestamibiTechnetium Tc 99m SestamibiCurium US LLCANDACurrent
69945-092Technetium Tc 99m SestamibiTechnetium Tc 99m SestamibiCurium US LLCANDACurrent
69945-092Technetium Tc 99m SestamibiTechnetium Tc 99m SestamibiCurium US LLCANDACurrent
69945-092Technetium Tc 99m SestamibiTechnetium Tc 99m SestamibiCurium US LLCANDACurrent
69945-092Technetium Tc 99m SestamibiTechnetium Tc 99m SestamibiCurium US LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22620ORIG2012-03-28
31331ORIG2008-09-23