Application 203684

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUMASONSULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERESFOR SUSPENSION;INTRAVENOUS60.7MG/25MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N203684-001LUMASONSULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203684-001102320612038-07-06Drug product2019-03-25
N203684-001103355022038-07-06Drug product2019-07-16
N203684-001117238692039-05-15U-3666Drug product2023-08-16
N203684-001117238692039-05-15U-3667Drug product2023-08-16
N203684-001117238692039-05-15U-3668Drug product2023-08-16

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-153f01610625f2…
2019-09-15 20:21 UTC2019-09N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N203684-001LUMASON60.7MG/25MGFOR SUSPENSION / INTRAVENOUSRLD, RS2014-10-15cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 4 · 145 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203684-001102320612038-07-06Drug product2019-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203684-001103355022038-07-06Drug product2019-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203684-001117238692039-05-15U-3666Drug product2023-08-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203684-001117238692039-05-15U-3667Drug product2023-08-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203684-001117238692039-05-15U-3668Drug product2023-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203684-001102320612038-07-06Drug product2019-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203684-001103355022038-07-06Drug product2019-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203684-001117238692039-05-15U-3666Drug product2023-08-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203684-001117238692039-05-15U-3667Drug product2023-08-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203684-001117238692039-05-15U-3668Drug product2023-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N203684-001102320612038-07-06Drug product2019-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203684-001103355022038-07-06Drug product2019-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203684-001117238692039-05-15U-3666Drug product2023-08-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203684-001117238692039-05-15U-3667Drug product2023-08-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203684-001117238692039-05-15U-3668Drug product2023-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203684-001102320612038-07-06Drug product2019-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203684-001103355022038-07-06Drug product2019-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203684-001117238692039-05-15U-3666Drug product2023-08-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203684-001117238692039-05-15U-3667Drug product2023-08-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203684-001117238692039-05-15U-3668Drug product2023-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203684-001102320612038-07-06Drug product2019-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203684-001103355022038-07-06Drug product2019-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203684-001117238692039-05-15U-3666Drug product2023-08-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203684-001117238692039-05-15U-3667Drug product2023-08-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203684-001117238692039-05-15U-3668Drug product2023-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203684-001102320612038-07-06Drug product2019-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203684-001103355022038-07-06Drug product2019-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203684-001117238692039-05-15U-3666Drug product2023-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203684-001117238692039-05-15U-3667Drug product2023-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203684-001117238692039-05-15U-3668Drug product2023-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203684-001102320612038-07-06Drug product2019-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203684-001103355022038-07-06Drug product2019-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203684-001117238692039-05-15U-3666Drug product2023-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203684-001117238692039-05-15U-3667Drug product2023-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203684-001117238692039-05-15U-3668Drug product2023-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203684-001102320612038-07-06Drug product2019-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203684-001103355022038-07-06Drug product2019-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203684-001117238692039-05-15U-3666Drug product2023-08-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203684-001117238692039-05-15U-3667Drug product2023-08-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203684-001117238692039-05-15U-3668Drug product2023-08-165bbf6a4d5a75…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203684-001NPP2022-11-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203684-001NPP2022-11-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203684-001NPP2022-11-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N203684-001I-7282019-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203684-001NCE2019-10-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203684-001NPP2022-11-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N203684-001NPP2022-11-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203684-001NPP2022-11-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N203684-001NPP2022-11-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N203684-001NPP2022-11-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N203684-001NPP2022-11-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N203684-001I-7282019-03-313f01610625f2…
2019-12-14 00:12 UTC2019-12N203684-001NCE2019-10-103f01610625f2…
2019-12-14 00:12 UTC2019-12N203684-001NPP2022-11-133f01610625f2…
2019-09-15 20:21 UTC2019-09N203684-001I-7282019-03-31b00525d2431f…
2019-09-15 20:21 UTC2019-09N203684-001NCE2019-10-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N203684-001I-7282019-03-31ea99ee380514…
2019-07-19 19:46 UTC2019-07N203684-001NCE2019-10-10ea99ee380514…
2023-01-26 05:58 UTC2023-01N203684-001NPP2022-11-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N203684-001NPP2022-11-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N203684-001NPP2022-11-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N203684-001NPP2022-11-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N203684-001NPP2022-11-13cb3db0bc1861…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LumasonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INC69822a55-226c-f133-e3b8-2b5826667c5b2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 203684
application number: NDA203684
ndc (product): 0270-7097
ndc (product): 0270-7099
LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INC7c679424-c3f7-ed02-892f-20ca0d7750892025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 203684
application number: NDA203684
ndc (product): 0270-7097
ndc (product): 0270-7099

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0270-7097LumasonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumasonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumasonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumasonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumasonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumasonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7097LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
0270-7099LumaSonSULFUR HEXAFLUORIDEBRACCO DIAGNOSTICS INCNDACurrent
68155-099LumaSonSULFUR HEXAFLUORIDEBracco Suisse SANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67032SUPPL2021-04-13
67018SUPPL2021-04-12
65492SUPPL2020-12-03
65496SUPPL2020-12-02
60845SUPPL2019-11-15
60832SUPPL2019-11-14
46527SUPPL2016-12-23
46514SUPPL2016-12-22
40321SUPPL2016-04-05
32459SUPPL2016-04-04
43442ORIG2014-12-05
40320ORIG2014-12-05
24445ORIG2014-12-05
32458ORIG2014-10-15
63276SUPPL1900-01-01
63275SUPPL1900-01-01
51669ORIG1900-01-01
51598ORIG1900-01-01
51597ORIG1900-01-01
51596ORIG1900-01-01