THEOPHYLLINE SODIUM GLYCINATE - Generic Drug Details

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What are the generic drug sources for theophylline sodium glycinate and what is the scope of freedom to operate?

Theophylline sodium glycinate is the generic ingredient in two branded drugs marketed by Cent Pharms and Novartis, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for theophylline sodium glycinate.

Summary for THEOPHYLLINE SODIUM GLYCINATE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	20
Patent Applications:	123
DailyMed Link:	THEOPHYLLINE SODIUM GLYCINATE at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for THEOPHYLLINE SODIUM GLYCINATE

R03DA	Xanthines
R03D	OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for THEOPHYLLINE SODIUM GLYCINATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ASBRON	theophylline sodium glycinate	TABLET;ORAL	085148-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cent Pharms	SYNOPHYLATE	theophylline sodium glycinate	ELIXIR;ORAL	006333-008	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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