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NDA

PROPOXYPHENE HYDROCHLORIDE | N010997 | 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

API Supply Chain0 active DMFs6 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

DINAMITE DIPHARMA SPAInactivePROPOXYPHENE HYDROCHLORIDE

DMF 13501969

GYMA LABORATORIES AMERICA INCInactivePROPOXYPHENE HYDROCHLORIDE

DMF 18221971

SIEGFRIED USA INCInactivePROPOXYPHENE HYDROCHLORIDE

DMF 27771976

MALLINCKRODT CHEMICAL INCInactivePROPOXYPHENE HYDROCHLORIDE

DMF 61551985

MALLINCKRODT INC THE PHARMACEUTICALS BUSINESS OF COVIDIENInactivePROPOXYPHENE HYDROCHLORIDE USP POWDER (E SUB)

DMF 140041999

CAMBREX CHARLES CITY INCInactivePROPOXYPHENE HYDROCHLORIDE

DMF 175022004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 32MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#003 — 65MG

0 patents0 exclusivities▾

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