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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

ORTHO TRI-CYCLEN 21

NDA

Tentative Approval

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

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TABLET; ORAL-21 | Approved: 2005-05-13 00:00:00

No patent or exclusivity listings for this strength.

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

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TABLET; ORAL-28 | Approved: 2005-05-13 00:00:00