FDA.reportPublic FDA data

Application 020976

Type
NDA
Sponsor
LIEBEL-FLARSHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPTIMARK IN PLASTIC CONTAINERGADOVERSETAMIDEINJECTABLE;INJECTION9927MG/30ML (330.9MG/ML)YesNo
002OPTIMARK IN PLASTIC CONTAINERGADOVERSETAMIDEINJECTABLE;INJECTION3309MG/10ML (330.9MG/ML)YesNo
003OPTIMARK IN PLASTIC CONTAINERGADOVERSETAMIDEINJECTABLE;INJECTION4963.5MG/15ML (330.9MG/ML)YesNo
004OPTIMARK IN PLASTIC CONTAINERGADOVERSETAMIDEINJECTABLE;INJECTION6618MG/20ML (330.9MG/ML)YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56433SUPPL2018-11-14
56290SUPPL2018-11-06
56289SUPPL2018-11-06
53898SUPPL2018-05-01
53844SUPPL2018-04-27
53843SUPPL2018-04-27
45220SUPPL2016-08-29
26347SUPPL2014-11-26
14062SUPPL2014-11-26
26346SUPPL2014-08-11
35761SUPPL2014-08-08
35760SUPPL2013-08-27
26345SUPPL2013-08-27
35759SUPPL2013-05-23
3902SUPPL2013-05-23
3901SUPPL2010-12-22
14061SUPPL2010-12-20
14060SUPPL2007-09-06
3900SUPPL2007-09-06
26344SUPPL2006-08-07
14059SUPPL2006-08-07
23612ORIG2006-06-09
26343SUPPL2005-11-30
35758SUPPL2004-06-10
26342SUPPL2004-06-10
21320SUPPL2004-01-29
41853ORIG1999-12-08
26341ORIG1999-12-08
14058ORIG1999-12-08