Viewing data from:

DARVOCET

NDA

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE | N016844 | AAIPHARMA LLC

1 strength0 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Mikart, Inc. FDA-1999-P-4073 · 7 docket documents Mikart, Incorporated filed a suitability petition requesting that the FDA amend the list of Drug Products Suitable for Abbreviated New Drug Applications to include Propoxyphene Napsylate and Acetaminophen Tablets/Capsules 50 mg/500 mg, a lower-strength variant of the reference listed drug DARVOCET-N	Other	2017-07-24	Denied	Mikart, Inc.
Barbara L. Maw, P.C. - Citizen Petition FDA-2011-P-0064 · 19 docket documents Barbara L. Maw, an attorney representing John and Jane Does 1-500, filed this citizen petition on January 20, 2011, requesting that the FDA vacate and revoke its voluntary recall of propoxyphene-containing products including Darvon and Darvocet pursuant to 21 U.S.C. Section 355(f) and 21 C.F.R. 10.3	Other	2011-01-31	Denied	—

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

Clinical Trials

1 trial from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
Lumbar Stenosis Outcomes Research II NCT00652093	Phase 4	Terminated	University of Rochester	24	2008-03 → 2011-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Products (1)

#001 — 325MG;32.5MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.