FDA.reportPublic FDA data

Application 200383

Type
ANDA
Sponsor
NAARI PTE LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG;0.035MG;0.035MG;0.18MG;0.215MG;0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-261Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolAkorn, Inc.ANDACurrent
17478-261Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolAkornANDACurrent
17478-261Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolAkorn, Inc.ANDACurrent
71205-170Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
71205-170Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
79929-009Norgestimate and ethinyl estradiolNorgestimate and ethinyl estradiolNaari Pte LimitedANDACurrent