FDA.reportPublic FDA data

Application 208612

Type
NDA
Sponsor
AVION PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BALCOLTRAETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL0.02MG;0.1MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42192-623levonorgestrel and ethinyl estradiollevonorgestrel and ethinyl estradiolAcella PharmaceuticalsNDACurrent
75854-602Balcoltralevonorgestrel and ethinyl estradiolAvion PharmaceuticalsNDACurrent
75854-602Balcoltralevonorgestrel and ethinyl estradiolAvion PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70972SUPPL2022-05-04
70953SUPPL2022-05-03
56741ORIG2018-12-14
51029ORIG2018-01-11
51026ORIG2018-01-11