Is there a generic for Dyphylline?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Dyphylline, referencing the brand NEOTHYLLINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dyphylline?

NEOTHYLLINE (NDA 007794, TEVA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dyphylline are approved?

Dyphylline is approved in the following dosage forms: elixir, injectable, tablet.

FDA Orange Book · active-ingredient family

Dyphylline

Dyphylline is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NEOTHYLLINE · NDA 007794

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · elixir, injectable, tablet

Product	Applicant	Application	TE	Approved
NEOTHYLLINE×3	TEVA	NDA 007794	—	Approved Prior to Jan 1, 1982
NEOTHYLLINE	TEVA	NDA 009088	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
DILOR	SAVAGE LABS	ANDA 084514	—	Approved Prior to Jan 1, 1982
DILOR-400	SAVAGE LABS	ANDA 084751	—	Approved Prior to Jan 1, 1982
LUFYLLIN×2	PHARMOBEDIENT	ANDA 084566	—	Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Dyphylline — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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