FDA.reportPublic FDA data

Application 021711

Type
NDA
Sponsor
LANTHEUS MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABLAVARGADOFOSVESET TRISODIUMSOLUTION;INTRAVENOUS2440MG/10ML (244MG/ML)NoNo
002ABLAVARGADOFOSVESET TRISODIUMSOLUTION;INTRAVENOUS3660MG/15ML (244MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021711-001ABLAVARGADOFOSVESET TRISODIUM2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22
N021711-002ABLAVARGADOFOSVESET TRISODIUM3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021711-001ABLAVAR2440MG/10ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021711-002ABLAVAR3660MG/15ML (244MG/ML)SOLUTION / INTRAVENOUS2008-12-22bb7c543d1eb4…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021711-00166769292020-05-04Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021711-00266769292020-05-04Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021711-00166769292020-05-04Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021711-00266769292020-05-04Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021711-00166769292020-05-04Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021711-00266769292020-05-04Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021711-00166769292020-05-04Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021711-00266769292020-05-04Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021711-00166769292020-05-04Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021711-00266769292020-05-04Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021711-00166769292020-05-04Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021711-00266769292020-05-04Drug productea99ee380514…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
16237SUPPL2013-08-09
6027SUPPL2013-08-08
23672ORIG2011-12-21
28433SUPPL2010-12-22
37498SUPPL2010-12-20
37497SUPPL2010-01-29
28432SUPPL2010-01-15
44643ORIG2009-04-02
21784ORIG2009-03-31
28431ORIG2009-01-02