FDA.reportPublic FDA data

Application 075478

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORTREL 7/7/7ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-210.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGNoNo
002NORTREL 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
0555-9012Nortrel 7/7/7Norethindrone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9012Nortrel 7/7/7Norethindrone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9012Nortrel 7/7/7Norethindrone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9012Nortrel 7/7/7Norethindrone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
71205-685Nortrel 7/7/7Norethindrone and Ethinyl EstradiolProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30905ORIG2004-06-10