規制動向
2026年9月17日•1分で読めます
FDA Approves Lupin Pharmaceuticals' FYAVOLV (Norethindrone Acetate/Ethinyl Estradiol)
The FDA has approved ANDA204213 for FYAVOLV, a prescription oral tablet combining norethindrone acetate and ethinyl estradiol, manufactured by Lupin Pharmaceuticals.
規制動向
2026年9月10日•1分で読めます
FDA Approves ANDA 076335 for TRI-PREVIFEM Oral Tablet
The FDA approved ANDA 076335 for the oral tablet TRI-PREVIFEM, containing ethinyl estradiol and norgestimate, sponsored by PH HEALTH. The product is listed as discontinued.
規制動向
2026年8月30日•1分で読めます
FDA Approves ORSYTHIA (ANDA077099) Oral Tablet
FDA has approved ANDA077099 for ORSYTHIA, an oral tablet containing ethinyl estradiol 0.02 mg and levonorgestrel 0.1 mg, sponsored by PH Health.
規制動向
2026年8月28日•1分で読めます
FDA Updates LOESTRIN 21 1.5/30 (NDA 017875) Submissions
FDA records show multiple labeling and manufacturing submissions for LOESTRIN 21 1.5/30, a discontinued oral contraceptive tablet, with the latest activity in May 2022.
規制動向
2026年8月25日•1分で読めます
FDA Approves ANDA078965 for Norethindrone/Ethinyl Estradiol/Ferrous Fumarate Tablet
The FDA has approved ANDA078965 for a prescription oral tablet combining norethindrone, ethinyl estradiol, and ferrous fumarate, submitted by BARR.