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ORTHO-NOVUM 7/7/7-21

NDA

ETHINYL ESTRADIOL; NORETHINDRONE | N018985 | JANSSEN PHARMACEUTICALS INC

2 strengths0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 21, 2017	SUPPL -64	View Letter (PDF)
Nov 4, 2015	SUPPL -63	View Letter (PDF)
Oct 4, 2013	SUPPL -60	View Letter (PDF)
Oct 4, 2013	SUPPL -50	View Letter (PDF)
Oct 4, 2013	SUPPL -54	View Letter (PDF)
Oct 4, 2013	SUPPL -56	View Letter (PDF)
Jun 20, 2012	SUPPL -53	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG

0 patents0 exclusivities▴

TABLET;ORAL-21 | Approved: Apr 4, 1984

No patent or exclusivity listings for this strength.

#002 — 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL-28 | Approved: Apr 4, 1984