Viewing data from:

LO/OVRAL

NDA

ETHINYL ESTRADIOL; NORGESTREL | N017612 | CADENCE HEALTH

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
American Medical Women's Association - Citizen Petition FDA-1994-P-0300 · 9 docket documents The American Medical Women's Association, American Public Health Association, and Planned Parenthood of New York City petitioned the FDA on November 23, 1994, to require manufacturers Wyeth-Ayerst Laboratories and Berlex Laboratories to relabel six oral contraceptives—Ovral, Lo/Ovral, Nordette, Trip	Other	2010-02-18	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.03MG;0.3MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL-21 | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.