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SYNOPHYLATE

NDA

THEOPHYLLINE SODIUM GLYCINATE | N006333 | CENTRAL PHARMACEUTICALS 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

2 trials from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage NCT05853601	Phase 1/2	Active	Medical College of Wisconsin	30	2023-10-17 → 2027-05
A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication NCT01875003	Phase 3	Terminated	Hoffmann-La Roche	346	2013-08-13 → 2016-12-28

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

API Supply Chain0 active DMFs1 inactive

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

STANDARD CHEM AND PHARM CO LTDInactiveTHEOPHYLLINE SODIUM GLYCINATE

DMF 188962005

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

Products (1)

#008 — EQ 165MG BASE/15ML

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.