FDA.reportPublic FDA data

Application 019853

Type
NDA
Sponsor
VALEANT PHARMS INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CUPRIMINEPENICILLAMINECAPSULE;ORAL250MGYesYes
002CUPRIMINEPENICILLAMINECAPSULE;ORAL125MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25010-705CupriminepenicillamineBausch Health Americas Inc.NDACurrent
25010-705CupriminepenicillamineBausch Health US, LLCNDACurrent
25010-705CupriminepenicillamineBausch Health US, LLCNDACurrent
25010-705CupriminepenicillamineBausch Health US, LLCNDACurrent
25010-705CupriminepenicillamineBausch Health Americas Inc.NDACurrent
25010-705CupriminepenicillamineBausch Health US, LLCNDACurrent
25010-705CupriminepenicillamineAton Pharma, Inc.NDACurrent
68682-020penicillaminepenicillamineOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-020penicillaminepenicillamineOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-020penicillaminepenicillamineOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-020CupriminepenicillamineOceanside Pharmaceuticals, Inc.NDACurrent
68682-020penicillaminepenicillamineOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-020penicillaminepenicillamineOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-020penicillaminepenicillamineOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52732SUPPL2018-02-27
52731SUPPL2018-02-27
11782SUPPL2004-11-01
11781SUPPL2004-11-01
19762SUPPL2004-10-29
1714SUPPL2004-10-29
19760SUPPL2003-11-25
1713SUPPL2003-11-25
34036SUPPL2003-06-08
19761SUPPL2003-06-08