FDA Approval Activities for this Drug…

DESOGESTREL; ETHINYL ESTRADIOL Tablet; -21 0.15MG;0.03MG DESOGESTREL AND ETHINYL ESTRADIOL DURAMED Barr 075863 DESOGESTREL; ETHINYL ESTRADIOL Tablet; -28 0.15MG;0.02MG;0.01MG KARIVA Barr 075256 DESOGESTREL; ETHINYL ESTRADIOL Tablet; -28 0.15MG;0.03MG DESOGESTREL AND ETHINYL ESTRADIOL DURAMED Barr 020713 DESOGESTREL; ETHINYL ESTRADIOL Tablet; -28 0.15MG;0.02MG,0.01MG MIRCETTE ORGANON USA INC 020071 DESOGESTREL; ETHINYL ESTRADIOL Tablet; -28 0.15MG;0.03MG DESOGEN ORGANON USA INC 021090 DESOGESTREL; ETHINYL ESTRADIOL Tablet; -28 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG CYCLESSA ORGANON USA INC 020301 DESOGESTREL; ETHINYL ESTRADIOL Tablet; -28 0.15MG;0.03MG ORTHO-CEPT ORTHO MCNEIL 021098 DROSPIRENONE; ETHINYL ESTRADIOL Tablet; -28 3MG;0.03MG YASMIN BERLEX 005292 ETHINYL ESTRADIOL Tablet; 0.02MG ESTINYL SCHERING 005292 ETHINYL ESTRADIOL Tablet; 0.05MG ESTINYL SCHERING 005292 ETHINYL ESTRADIOL Tablet; 0.5MG ESTINYL SCHERING 018168 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Tablet; -21 0.035MG;1MG DEMULEN 1/35-21 GD SEARLE 016927 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Tablet; -21 0.05MG;1MG DEMULEN 1/50-21 GD SEARLE 072720 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Tablet; -21 0.035MG;1MG ZOVIA 1/35E-21 Watson 072722 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Tablet; -21 0.05MG;1MG ZOVIA 1/50E-21 Watson 018160 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Tablet; -28 0.035MG;1MG DEMULEN 1/35-28 GD SEARLE 016936 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Tablet; -28 0.05MG;1MG DEMULEN 1/50-28 GD SEARLE 072721 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Tablet; -28 0.035MG;1MG ZOVIA 1/35E-28 Watson 072723 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Tablet; -28 0.05MG;1MG ZOVIA 1/50E-28 Watson 021187 ETHINYL ESTRADIOL; ETONOGESTREL Ring; Vaginal 0.015MG;0.12MG NUVARING ORGANON USA INC 021544 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; 0.03MG;0.15MG SEASONALE Barr 020946 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; 0.05MG;0.25MG PREVEN EMERGENCY CONTRACEPTIVE KIT GYNETICS 075862 AB1 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -21 0.02MG;0.1MG LEVONORGESTREL AND ETHINYL ESTRADIOL Barr 075803 AB2 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -21 0.02MG;0.1MG LESSINA-21 Barr 075866 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -21 0.03MG;0.15MG PORTIA-21 Barr 020860 AB2 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -21 0.02MG;0.1MG LEVLITE BERLEX 075796 AB1 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -21 0.02MG;0.1MG AVIANE-21 DURAMED Barr 075809 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -21 0.03MG,0.05MG,0.075MG;0.04MG,0.03MG,0.125MG ENPRESSE-21 DURAMED Barr 074538 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -21 0.03MG;0.04MG;0.03MG;0.05MG;0.125MG;0.075MG TRIVORA-21 Watson 073592 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -21 0.03MG;0.15MG LEVORA 0.15/30-21 Watson 020683 AB1 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -21 0.02MG;0.1MG ALESSE Wyeth INC 019192 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -21 0.03MG;0.04MG;0.03MG;0.05MG;0.125MG;0.075MG TRIPHASIL-21 Wyeth INC 018668 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -21 0.03MG;0.15MG NORDETTE-21 Wyeth INC 075803 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.02MG;0.1MG LESSINA-28 Barr 075862 AB1 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.02MG;0.1MG LEVONORGESTREL AND ETHINYL ESTRADIOL Barr 075866 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.03MG;0.15MG PORTIA-28 Barr 020860 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.02MG;0.1MG LEVLITE BERLEX 075796 AB1 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.02MG;0.1MG AVIANE-28 DURAMED Barr 075809 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.03MG,0.03MG,0.075MG;0.04MG,0.05MG,0.125MG ENPRESSE-28 DURAMED Barr 074538 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.03MG;0.04MG;0.03MG;0.05MG;0.125MG;0.075MG TRIVORA-28 Watson 073594 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.03MG;0.15MG LEVORA 0.15/30-28 Watson 020683 AB1 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.02MG;0.1MG ALESSE Wyeth INC 019190 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.03MG;0.04MG;0.03MG;0.05MG;0.125MG;0.075MG TRIPHASIL-28 Wyeth INC 018782 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.03MG;0.15MG NORDETTE-28 Wyeth INC 021180 ETHINYL ESTRADIOL; NORELGESTROMIN Film, Extended Release; Transdermal 0.02MG/24HR;0.015MG/24HR ORTHO EVRA ORTHO MCNEIL 075478 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.75MG NORTREL 7/7/7 Barr 072694 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;0.035MG;0.5MG;1MG GENCEPT 10/11-21 Barr 072692 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;0.5MG NORTREL 0.5/35-21 Barr 072693 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;1MG NORTREL 1/35-21 Barr 071545 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;1MG NORCEPT-E 1/35 21 GYNOPHARMA 018127 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;0.4MG OVCON-35 WARNER CHILCOTT 071043 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;0.035MG;0.5MG;1MG NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) Watson 071041 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;0.035MG;0.5MG;1MG NORETHINDRONE AND ETHINYL ESTRADIOL (7/14) Watson 070684 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;0.5MG NORETHINDRONE AND ETHINYL ESTRADIOL Watson 017566 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;0.5MG BREVICON 21-DAY Watson 017565 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;1MG NORINYL 1+35 21-DAY Watson 070685 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;1MG NORETHINDRONE AND ETHINYL ESTRADIOL Watson 071480 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -21 0.035MG;1MG NORETHIN 1/35E-21 Watson 075478 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG,0.035MG,0.035MG;0.05MG,0.75MG,1MG NORTREL 7/7/7 Barr 072697 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;0.035MG;0.5MG;1MG GENCEPT 10/11-28 Barr 072695 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;0.5MG NORTREL 0.5/35-28 Barr 072696 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;1MG NORTREL 1/35-28 Barr 071546 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;1MG NORCEPT-E 1/35 28 GYNOPHARMA 018985 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.75MG ORTHO-NOVUM 7/7/7-28 ORTHO MCNEIL 019004 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;0.035MG;0.5MG;1MG ORTHO-NOVUM 7/14-28 ORTHO MCNEIL 018354 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;0.035MG;0.5MG;1MG ORTHO-NOVUM 10/11-28 IN PLASTIC CONTAINER ORTHO MCNEIL 017735 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;0.5MG MODICON 28 ORTHO MCNEIL 017919 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;1MG ORTHO-NOVUM 1/35-28 ORTHO MCNEIL 017716 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;0.4MG OVCON-35 WARNER CHILCOTT 017576 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.05MG;1MG OVCON-50 WARNER CHILCOTT 018977 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TRI-NORINYL 28-DAY Watson 071044 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;0.035MG;0.5MG;1MG NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) Watson 071042 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;0.035MG;0.5MG;1MG NORETHINDRONE AND ETHINYL ESTRADIOL (7/14) Watson 070686 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;0.5MG NORETHINDRONE AND ETHINYL ESTRADIOL Watson 017743 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;0.5MG BREVICON 28-DAY Watson 070687 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;1MG NORETHINDRONE AND ETHINYL ESTRADIOL Watson 071481 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;1MG NORETHIN 1/35E-28 Watson 017565 ETHINYL ESTRADIOL; NORETHINDRONE Tablet; -28 0.035MG;1MG NORINYL 1+35 28-DAY Watson 021065 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; 0.005MG;1MG FEMHRT GALEN CHEM 076380 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; -21 0.02MG;1MG JUNEL 1/20 Barr 076381 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; -21 0.03MG;1.5MG JUNEL 1.5/30 Barr 017876 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; -21 0.02MG;1MG LOESTRIN 21 1/20 GALEN CHEM 017875 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; -21 0.03MG;1.5MG LOESTRIN 21 1.5/30 GALEN CHEM 076081 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; -28 0.02MG;1MG JUNEL FE 1/20 Barr 076064 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; -28 0.03MG;1.5MG JUNEL FE 1.5/30 Barr 020130 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; -28 0.02MG;0.03MG;0.035MG;1MG;1MG;1MG ESTROSTEP FE GALEN CHEM 017354 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; -28 0.02MG;1MG LOESTRIN FE 1/20 GALEN CHEM 017355 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; -28 0.03MG;1.5MG LOESTRIN FE 1.5/30 GALEN CHEM 075647 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; -28 0.02MG;1MG MICROGESTIN FE 1/20 Watson 075548 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Tablet; -28 0.03MG;1.5MG MICROGESTIN FE 1.5/30 Watson 075804 ETHINYL ESTRADIOL; NORGESTIMATE Tablet; -28 0.035MG;0.25MG SPRINTEC Barr 021241 ETHINYL ESTRADIOL; NORGESTIMATE Tablet; -28 0.025MG,0.025MG,0.25MG;0.18MG,0.25MG,0.215MG ORTHO TRI-CYCLEN LO JOHNSON AND JOHNSON 019697 ETHINYL ESTRADIOL; NORGESTIMATE Tablet; -28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG ORTHO TRI-CYCLEN ORTHO MCNEIL 019653 ETHINYL ESTRADIOL; NORGESTIMATE Tablet; -28 0.035MG;0.25MG ORTHO CYCLEN-28 ORTHO MCNEIL 075840 ETHINYL ESTRADIOL; NORGESTREL Tablet; -21 0.03MG;0.3MG CRYSELLE DURAMED Barr 075288 ETHINYL ESTRADIOL; NORGESTREL Tablet; -21 0.03MG;0.3MG LOW-OGESTREL-21 Watson 075406 ETHINYL ESTRADIOL; NORGESTREL Tablet; -21 0.05MG;0.5MG OGESTREL 0.5/50-21 Watson 017612 ETHINYL ESTRADIOL; NORGESTREL Tablet; -21 0.03MG;0.3MG LO/OVRAL Wyeth INC 016672 ETHINYL ESTRADIOL; NORGESTREL Tablet; -21 0.05MG;0.5MG OVRAL Wyeth INC 075840 ETHINYL ESTRADIOL; NORGESTREL Tablet; -28 0.03MG;0.3MG CRYSELLE DURAMED Barr 075288 ETHINYL ESTRADIOL; NORGESTREL Tablet; -28 0.03MG;0.3MG LOW-OGESTREL-28 Watson 075406 ETHINYL ESTRADIOL; NORGESTREL Tablet; -28 0.05MG;0.5MG OGESTREL 0.5/50-28 Watson 017802 ETHINYL ESTRADIOL; NORGESTREL Tablet; -28 0.03MG;0.3MG LO/OVRAL-28 Wyeth INC 016806 ETHINYL ESTRADIOL; NORGESTREL Tablet; -28 0.05MG;0.5MG OVRAL-28 Wyeth INC Ovcon 35 (norethindrone and ethinyl estradiol) tablets, chewable, Warner Chilcott Norgestimate and Ethinyl Estradiol Tablets, Andrx Pharmaceuticals Femhrt (norethindrone acetate/ethinyl estradiol), Tablets, Galen (Chemicals) Limited Cyclessa (desogestrel/ethinyl estradiol) Tablet, Organon, Inc. Desogestrel & Ethinyl Estradiol Tablets, Barr Laboratories NuvaRing (Etonogestrel/Ethinyl Estradiol) Vaginal Ring, Organon, Inc. Desogen (desogestrel/ethinyl estradiol) Tablets, Organon USA, Inc., Labeling Revision | Aranelle (Norethindrone & Ethinyl Estradiol) Tablets, Barr Laboratories, Approval | Nevis (Norethindrone Acetate & Ethinyl Estradiol) Tablets, Barr Labs, Tentative Approval | Levonorgestrel & Ethinyl Estradiol Tablets, Watson Labs, Approval | ORTHO-EVRA (norelgestromin/ethinyl estradiol transdermal system), Johnson & Johnson Pharma, Control Supplement | Femhrt (norethindrone acetate/ethinyl estradiol tablets), Warner Chilcott Company, New Dosage Regimen | ORTHO EVRA (norelgestromin/ethinyl estradiol) transdermal system, Johnson & Johnson Pharma, Labeling Revision

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