Dyphylline

Sold as Neothylline. Every FDA application for this active ingredient: 2 branded and 3 generic.

As of Nov 13, 2026, FDA lists 5 applications for Dyphylline (sold as Neothylline), first approved Mar 7, 1951, with 0 new uses approved and 0 published complete response letters.

First approved: Mar 7, 1951
Applications: 5
New uses approved: 0
Complete response letters: 0

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
DILIN - Prospective StudyLiver Diseases · Duke University	—	Recruiting	Jun 29, 2006

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Mar 7, 1951	NeothyllineNDA 7794 · New molecular entity	Teva	0	Discontinued
Sep 28, 1953	NeothyllineNDA 9088 · New dosage form	Teva	2	Discontinued
Aug 16, 1976	DilorANDA 84514	Savage Labs	10	Discontinued
Aug 16, 1976	LufyllinANDA 84566	Pharmobedient	11	Discontinued
Aug 16, 1976	Dilor-400ANDA 84751	Savage Labs	8	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA