FDA Approval Activities for this Drug…

Aviane-21 and Aviane-28 Tablets, (Levonorgestrel & Ethinyl Estradiol Tablets USP, 0.1 mg & 0.02 mg, respectively), Duramed ANDA 75-796 Lessina-21 & Lessina-28 (Levonorgestrel & Ethinyl Estradiol) Tablets USP, 0.1 & 0.02 mg, Barr, ANDA 75-803 Levlite (levonorgestrel 0.100 mg and ethinyl estradiol Tablets, 0.020 mg) Berlex NDA 20-860 Levonorgestrel and Ethinyl Estradiol Tablets, Barr, ANDA 75-862 4/29/03 Levonorgestrel Tablets, 0.75mg, Women's Capital NDA 21-045 Mirena (levonorgestrel-releasing intrauterine system), Berlex NDA 21-225/S10 8/27/03 08/29/03 Mirena (levonorgestrel-releasing intrauterine system) Intrauterine delivery system,20 mcgs/day of levonorgestrel/5-year, Berlex NDA 21-225 12/6/00 Mirena Indications: Intrauterine Contraception. NORPLANT SYSTEM (levonorgestrel implant) Wyeth Ayerst , NDA 20-088/S-016 Portia (Levonorgestrel and Ethinyl Estradiol) Tabelts, Barr, ANDA 75-866 Preven Emergency Contraceptive Kit (Levonorgestrel and ethinyl estradiol) tablets, Gynetics, NDA 20-946/S001 6/7/99 7/11/00 Preven Emergency Contraceptive Kit (Levonorgestrel 0.25 mg and ethinyl estradiol 0.05 mg ) tablets, Gynetics NDA 20-946 9/1/98 9/3/98 9/3/98 7/8/99 Preven Indication: emergency contraceptive for the prevention of pregnancy. Seasonale (Levonorgestrel/Ethinyl Estradiol) Tablets, Barr NDA 21-544 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 075862 AB1 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.02MG;0.1MG LEVONORGESTREL AND ETHINYL ESTRADIOL Barr 075803 ETHINYL ESTRADIOL; LEVONORGESTREL Tablet; -28 0.02MG;0.1MG LESSINA-28 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 020544 BX LEVONORGESTREL Implant; Implantation 75MG/IMPLANT NORPLANT II POPULATION COUNCIL 021225 LEVONORGESTREL Intrauterine Device; Intrauterine 52MG MIRENA BERLEX 021045 LEVONORGESTREL Tablet; 0.75MG PLAN B WOMENS CAPITAL NORPLANT SYSTEM (levonorgestrel implant), Wyeth Pharmaceuticals | Levonorgestrel & Ethinyl Estradiol Tablets, Watson Labs, Approval

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