Application 075321

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDECAPSULE;ORAL5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-0055SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDEApotex Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8618ORIG1998-12-04