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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

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
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.