Application 075406

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OGESTREL 0.5/50-21ETHINYL ESTRADIOL; NORGESTRELTABLET;ORAL-210.05MG;0.5MGNoNo
002OGESTREL 0.5/50-28ETHINYL ESTRADIOL; NORGESTRELTABLET;ORAL-280.05MG;0.5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52544-848OgestrelNorgestrel and Ethinyl EstradiolActavis Pharma, Inc.ANDACurrent
52544-848OgestrelNorgestrel and Ethinyl EstradiolActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8654SUPPL2013-04-24
39484SUPPL2013-04-23
30874ORIG1999-12-15