ETHINYL ESTRADIOL | N005292 | SCHERING CORP SUB SCHERING PLOUGH CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Duramed Research, Inc. 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21-544 for Seasonale (0.03 mg ethinyl estradiol/0.15 mg levonorgestrel) to conduct bioequiva | 505(q) | 2009-03-24 | Withdrawn | Duramed Research, Inc. |
Warner Chilcott - Citizen Petition FDA-2008-P-0587 · 3 docket documents Warner Chilcott Company, Inc. submitted this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require any ANDA relying on Loestrin 24 Fe Tablets (norethindrone acetate 1 mg and ethinyl estradiol 20 mcg with ferrous fumarate, NDA 21-871) as the re | 505(q) | 2008-12-11 | Granted | — |
Public Citizen - Citizen Petition FDA-2008-P-0296 · 20 docket documents Public Citizen filed this citizen petition pursuant to 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30, requesting that the FDA ban the transdermal contraceptive patch Ortho-Evra (ethinyl estradiol/norelgestromin, manufactured by Johnson & Johnson) with market removal within six months, citing evide | Other | 2008-06-12 | Denied | — |
Citizen Petition from Warner Chilcott Inc. FDA-2007-P-0171 · 5 docket documents Warner Chilcott Inc. filed this petition requesting that the Food and Drug Administration refrain from approving abbreviated new drug applications for 0.4 mg Norethindrone and 35 µg Ethinyl Estradiol chewable tablets unless applicants demonstrate bioequivalence to both Ovcon-35 Oral Tablets and Femc | 505(q) Stay Request | 2008-05-06 | Denied | Warner Chilcott Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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