FDA.reportPublic FDA data

Application 020937

Type
NDA
Sponsor
LIEBEL-FLARSHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPTIMARKGADOVERSETAMIDEINJECTABLE;INJECTION1654.5MG/5ML (330.9MG/ML)YesNo
002OPTIMARKGADOVERSETAMIDEINJECTABLE;INJECTION3309MG/10ML (330.9MG/ML)YesNo
003OPTIMARKGADOVERSETAMIDEINJECTABLE;INJECTION4963.5MG/15ML (330.9MG/ML)YesNo
004OPTIMARKGADOVERSETAMIDEINJECTABLE;INJECTION6618MG/20ML (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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020937-001OPTIMARKGADOVERSETAMIDE1654.5MG/5ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08
N020937-002OPTIMARKGADOVERSETAMIDE3309MG/10ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08
N020937-003OPTIMARKGADOVERSETAMIDE4963.5MG/15ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08
N020937-004OPTIMARKGADOVERSETAMIDE6618MG/20ML (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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020937-001OPTIMARK1654.5MG/5ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0884e616aacf4f…
2026-09-14 22:38:342026-08N020937-002OPTIMARK3309MG/10ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0884e616aacf4f…
2026-09-14 22:38:342026-08N020937-003OPTIMARK4963.5MG/15ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0884e616aacf4f…
2026-09-14 22:38:342026-08N020937-004OPTIMARK6618MG/20ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0884e616aacf4f…
2026-08-18 06:07:402026-07N020937-001OPTIMARK1654.5MG/5ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07N020937-002OPTIMARK3309MG/10ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07N020937-003OPTIMARK4963.5MG/15ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07N020937-004OPTIMARK6618MG/20ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020937-001OPTIMARK1654.5MG/5ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020937-002OPTIMARK3309MG/10ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020937-003OPTIMARK4963.5MG/15ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020937-004OPTIMARK6618MG/20ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020937-001OPTIMARK1654.5MG/5ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020937-002OPTIMARK3309MG/10ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020937-003OPTIMARK4963.5MG/15ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020937-004OPTIMARK6618MG/20ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020937-001OPTIMARK1654.5MG/5ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020937-002OPTIMARK3309MG/10ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020937-003OPTIMARK4963.5MG/15ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020937-004OPTIMARK6618MG/20ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020937-001OPTIMARK1654.5MG/5ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020937-002OPTIMARK3309MG/10ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020937-003OPTIMARK4963.5MG/15ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020937-004OPTIMARK6618MG/20ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020937-001OPTIMARK1654.5MG/5ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020937-002OPTIMARK3309MG/10ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020937-003OPTIMARK4963.5MG/15ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020937-004OPTIMARK6618MG/20ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020937-001OPTIMARK1654.5MG/5ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020937-002OPTIMARK3309MG/10ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020937-003OPTIMARK4963.5MG/15ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020937-004OPTIMARK6618MG/20ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020937-001OPTIMARK1654.5MG/5ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020937-002OPTIMARK3309MG/10ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020937-003OPTIMARK4963.5MG/15ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020937-004OPTIMARK6618MG/20ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020937-001OPTIMARK1654.5MG/5ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020937-002OPTIMARK3309MG/10ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020937-003OPTIMARK4963.5MG/15ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020937-004OPTIMARK6618MG/20ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-085bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56431SUPPL2018-11-14
56291SUPPL2018-11-06
56286SUPPL2018-11-06
53896SUPPL2018-05-01
53840SUPPL2018-04-27
53837SUPPL2018-04-27
45222SUPPL2016-08-29
26246SUPPL2014-11-26
13780SUPPL2014-11-26
3807SUPPL2014-08-11
35677SUPPL2014-08-08
26245SUPPL2013-08-27
13779SUPPL2013-08-27
35676SUPPL2013-05-23
26244SUPPL2013-05-23
26243SUPPL2010-12-22
13778SUPPL2010-12-20
35675SUPPL2007-09-06
26242SUPPL2007-09-06
35674SUPPL2006-08-07
3806SUPPL2006-08-07
44080ORIG2006-06-09
3805SUPPL2005-11-30
26241SUPPL2004-06-10
13777SUPPL2004-06-10
41825SUPPL2004-01-29
35673ORIG1999-12-08
26240ORIG1999-12-08
21290ORIG1999-12-08