FDA.reportPublic FDA data

Application 076338

Type
ANDA
Sponsor
VINTAGE PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLAFEM 7/7/7ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-7525Cyclafem 7/7/7norethindrone and ethinyl estradiolPar Pharmaceutical, Inc.ANDACurrent
0603-7525Cyclafem 7/7/7norethindrone and ethinyl estradiolPar PharmaceuticalANDACurrent
0603-7525Cyclafem 7/7/7norethindrone and ethinyl estradiolPar PharmaceuticalANDACurrent
50090-2006Cyclafem 7/7/7norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
76413-104Cyclafem 7/7/7norethindrone and ethinyl estradiolCentral Texas Community Health CentersANDACurrent