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New and Generic Drug Approvals


June 18, 2012
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Abacavir Sulfateabacavir sulfateTablet; OralMylan Pharms IncApproval
Modicon 28ethinyl estradiol; norethindroneTablet; Oral-28Janssen PharmsLabeling Revision
Ortho Cyclen-21ethinyl estradiol; norgestimateTablet; Oral-21Janssen PharmsLabeling Revision
Ortho Cyclen-28ethinyl estradiol; norgestimateTablet; Oral-28Janssen PharmsLabeling Revision
Ortho Tri-Cyclenethinyl estradiol; norgestimateTablet; Oral-21Janssen PharmsLabeling Revision
Ortho Tri-Cyclenethinyl estradiol; norgestimateTablet; Oral-28Janssen PharmsLabeling Revision
Ortho Tri-Cyclen Loethinyl estradiol; norgestimateTablet; Oral-28Janssen PharmsLabeling Revision
Ortho-Ceptdesogestrel; ethinyl estradiolTablet; Oral-21Janssen PharmsLabeling Revision
Ortho-Ceptdesogestrel; ethinyl estradiolTablet; Oral-28Janssen PharmsLabeling Revision
Ortho-Novum 1/35-28ethinyl estradiol; norethindroneTablet; Oral-28Janssen PharmsLabeling Revision
Ortho-Novum 7/7/7-21ethinyl estradiol; norethindroneTablet; Oral-21Janssen PharmsLabeling Revision
Ortho-Novum 7/7/7-28ethinyl estradiol; norethindroneTablet; Oral-28Janssen PharmsLabeling Revision

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