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DARVOCET-N 50

NDA

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE | N017122 | XANODYNE PHARMACEUTICS 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

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Services, Inc. - CP1 Attachment 1 FDA-2006-P-0456 · 8 docket documents This document is a search results page from the FDA's Orange Book showing application number 017122, which lists two formulations of Darvocet-N (acetaminophen and propoxyphene napsylate) tablets in 325mg/50mg and 650mg/100mg strengths manufactured by Xanodyne Pharmaceuticals as reference listed drug	Other	2008-07-14	Granted	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 13, 2009	SUPPL -61	View Letter (PDF)
Oct 26, 2009	SUPPL -62	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 650MG;100MG

0 patents0 exclusivities▾

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

#001 — 325MG;50MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.