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 44.

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020975-001OPTIMARK16.545GM/50ML (330.9MG/ML)INJECTABLE / INJECTIONRLD1999-12-08a50c72e98297…

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