FDA.reportPublic FDA data

Application 020697

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TASMARTOLCAPONETABLET;ORAL100MGYesYes
002TASMARTOLCAPONETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0938TasmarTolcaponeBausch Health US LLCNDACurrent
0187-0938TasmarTolcaponeBausch Health US LLCNDACurrent
0187-0938TasmarTolcaponeValeant Pharmaceuticals North America LLCNDACurrent
68682-938TolcaponeTolcaponeOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-938TolcaponeTolcaponeOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
35151SUPPL2013-05-14
3096SUPPL2013-05-14
3099SUPPL2009-07-07
25530SUPPL2009-02-13
3098SUPPL2009-02-13
13220SUPPL2009-02-10
13219SUPPL2009-02-10
25529SUPPL2007-02-02
13218SUPPL2007-01-25
3097SUPPL2006-03-01
13217SUPPL2006-02-22
20830ORIG2002-04-09
35150ORIG1998-01-29
3095ORIG1998-01-29