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  FDA Approval Activities for this Drug…

Cyclessa (desogestrel/ethinyl estradiol) Tablet,Rx Organon, NDA 21-090 12/20/00 Cyclessa Indications: Contraception Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively, Duramed ANDA 75-863 11/29/01 4/15/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively Duramed ANDA 75-256/S7 06/19/02 8/24/99 8/6/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively Duramed ANDA 75-256/S6 07/27/01 8/24/99 8/6/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively Duramed ANDA 75-256/S5 07/27/01 8/24/99 8/6/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively Duramed ANDA 75-256/S4 07/11/01 8/24/99 8/6/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively Duramed ANDA 75-256/S3 11/14/01 8/24/99 8/6/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively Duramed ANDA 75-256/S2 06/28/01 8/24/99 8/6/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively Duramed ANDA 75-256/S1 10/28/99 8/24/99 8/6/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively Duramed ANDA 75-256 Kariva (Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol) Tablets, Barr, ANDA 75-863 Mircette/Desogestrel/ethinyl estradiol and ethinyl estradiol tablets Organon, Inc NDA 20-713 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 Cyclessa (desogestrel/ethinyl estradiol) Tablet, Organon, Inc. Desogestrel & Ethinyl Estradiol Tablets, Barr Laboratories Desogen (desogestrel/ethinyl estradiol) Tablets, Organon USA, Inc., Labeling Revision | Desogestrel & Ethinyl Estradiol Tablets, Wastson Labs, Approval | Desogestrel and Ethinyl Estradiol Tablet, Watson Labs, Approval

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