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DARVON-N

NDA

PROPOXYPHENE NAPSYLATE | N016862 | XANODYNE PHARMACEUTICS INC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs5 inactive

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

SIEGFRIED AGInactivePROPOXYPHENE NAPSYLATE

DMF 35111979

AAI PHARMA LLCInactivePROPOXYPHENE NAPSYLATE

DMF 48801983

AAI PHARMA LLCInactivePROPOXYPHENE NAPSYLATE PRODUCED BY TIPPECANOE LABS IN LAFAYETTE, IN.

DMF 54771984

MALLINCKRODT CHEMICAL INCInactivePROPOXYPHENE NAPSYLATE

DMF 61361985

CAMBREX CHARLES CITY INCInactivePROPOXYPHENE NAPSYLATE

DMF 175032004

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 (1)

#002 — 100MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.