Application 087313

Type
ANDA
Sponsor
OLTA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LINDANELINDANELOTION;TOPICAL1%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61748-401LindaneLindaneVersaPharm IncorporatedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52761ORIG2018-02-28
44408ORIG2003-12-17