FDA.reportPublic FDA data

Application 020975

Type
NDA
Sponsor
LIEBEL-FLARSHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPTIMARKGADOVERSETAMIDEINJECTABLE;INJECTION16.545GM/50ML (330.9MG/ML)YesNo

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
N020975-001OPTIMARKGADOVERSETAMIDE16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08

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 22:38:342026-08N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0884e616aacf4f…
2026-08-18 06:07:402026-07N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56432SUPPL2018-11-14
56288SUPPL2018-11-06
56287SUPPL2018-11-06
53897SUPPL2018-05-01
53842SUPPL2018-04-27
53841SUPPL2018-04-27
45221SUPPL2016-08-29
14057SUPPL2014-11-26
3899SUPPL2014-11-26
26340SUPPL2014-08-11
35757SUPPL2014-08-08
26339SUPPL2013-08-27
14056SUPPL2013-08-27
35756SUPPL2013-05-23
3898SUPPL2013-05-23
3897SUPPL2010-12-22
14055SUPPL2010-12-20
14053SUPPL2008-08-26
3895SUPPL2008-08-20
14054SUPPL2007-09-06
3896SUPPL2007-09-06
35755SUPPL2006-08-07
3894SUPPL2006-08-07
44083ORIG2006-06-09
26338SUPPL2005-11-30
14052SUPPL2004-06-10
3893SUPPL2004-06-10
41852SUPPL2004-01-29
35754ORIG1999-12-08
26337ORIG1999-12-08
21319ORIG1999-12-08