FDA.reportPublic FDA data

Application 021479

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZELAPARSELEGILINE HYDROCHLORIDETABLET, ORALLY DISINTEGRATING;ORAL1.25MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0453ZELAPARSELEGILINE HYDROCHLORIDEValeant Pharmaceuticals North America LLCNDACurrent
0187-0453ZELAPARSELEGILINE HYDROCHLORIDEBausch Health US, LLCNDACurrent
0187-0453ZELAPARSELEGILINE HYDROCHLORIDEBausch Health US, LLCNDACurrent
0187-0453ZELAPARSELEGILINE HYDROCHLORIDEValeant Pharmaceuticals North America LLCNDACurrent
0187-0453ZELAPARSELEGILINE HYDROCHLORIDEValeant Pharmaceuticals North America LLCNDACurrent
0187-0453ZELAPARSELEGILINE HYDROCHLORIDEBausch Health US, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67838SUPPL2021-06-17
67836SUPPL2021-06-17
59753SUPPL2019-08-20
15566SUPPL2014-08-19
5497SUPPL2014-08-01
21684ORIG2009-01-15
37035SUPPL2009-01-06
27897SUPPL2009-01-06
15565SUPPL2009-01-06
5496SUPPL2009-01-06
27896ORIG2006-06-20
15564ORIG2006-06-20