JADELLE

FDA-2013-P-0886 · 5 docket documents

Arnall Golden Gregory LLP filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Population Council's Norplant II Levonorgestrel Implants (Jadelle) (NDA #020544) was voluntarily withdrawn from the market for reasons other than

FDA-2001-P-0123 · 52 docket documents

The Center for Reproductive Law & Policy, on behalf of the American Public Health Association, the American Medical Women's Association, the Association of Reproductive Health Professionals, and fifty-eight other organizations, filed a citizen petition on February 14, 2001, requesting that the FDA e

FDA-2006-P-0348 · 5 docket documents

Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals, filed this citizen petition on July 14, 2006, requesting that the FDA require all Abbreviated New Drug Applications referencing Duramed's NDA No. 21-544 for Seasonale (0.03 mg ethinyl estradiol/0.15 mg levonorgestrel) to conduct bioequiva

FDA-2006-P-0018 · 28 docket documents

The State of Wisconsin, through its Attorney General, filed this citizen petition pursuant to 21 CFR §§ 10.25(a), 10.30, and 10.33 requesting that the FDA switch Plan B (levonorgestrel), an emergency contraceptive drug approved in 1999 for prescription use, and any equivalent drugs to over-the-count