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NDA

PERFLUBRON | N020091 | ALLIANCE PHARMACEUTICAL CORP

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Solvay Pharmaceuticals FDA-1998-P-0083 · 32 docket documents Solvay Pharmaceuticals filed a citizen petition requesting that the FDA take regulatory action regarding the approval status and labeling requirements for extended-release formulations of their drug product under the NDA (New Drug Application) framework. The petition sought FDA guidance on bioequiva	Other	2026-06-11	WithdrawnNo FDA response document on docket	Solvay Pharmaceuticals

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

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase1, Placebo-Controlled, Randomized, Double-blind, Single-ascending Dose Study in Healthy Subjects.NCT02616770	Phase 1	Completed	SolAeroMed Inc.	36	2014-03 → 2014-05
Fluid Filled Lung Oxygenation Assistance Trial NCT03041740	Phase 1	Completed	Children's Hospital of Philadelphia	16	2017-06-27 → 2019-06-10

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Products (1)

#001 — 100%

0 patents0 exclusivities▴

LIQUID;ORAL | Approved: Aug 13, 1993

No patent or exclusivity listings for this strength.