Last Updated: September 24, 2026

Details for New Drug Application (NDA): 006333

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NDA 006333 describes SYNOPHYLATE, which is a drug marketed by Cent Pharms and is included in one NDA. Additional details are available on the SYNOPHYLATE profile page.

The generic ingredient in SYNOPHYLATE is theophylline sodium glycinate. There is one drug master file entry for this compound. Additional details are available on the theophylline sodium glycinate profile page.

Summary for 006333

Tradename:	SYNOPHYLATE
Applicant:	Cent Pharms
Ingredient:	theophylline sodium glycinate
Patents:	0

Profile for product number 008

Active Rx/OTC/Discontinued:	DISCN	Dosage:	ELIXIR;ORAL			Strength	EQ 165MG BASE/15ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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