Viewing data from:

Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

ORTHO TRI-CYCLEN 21

NDANot in Orange Book

ETHINYL ESTRADIOL; NORGESTIMATE | N021690 | ORTHO MCNEIL PHARM

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 4, 2015	SUPPL -1	View Letter (PDF)
May 17, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

▴

TABLET; ORAL-21 | Approved: May. 13, 2005

No patent or exclusivity listings for this strength.

#002 — 0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

▾

TABLET; ORAL-28 | Approved: May. 13, 2005