Is there a generic for Procaine merethoxylline; theophylline?

The FDA Orange Book does not currently list an approved generic (ANDA) for Procaine merethoxylline; theophylline. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Procaine merethoxylline; theophylline?

DICURIN PROCAINE (NDA 008869, LILLY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Procaine merethoxylline; theophylline are approved?

Procaine merethoxylline; theophylline is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Procaine merethoxylline; theophylline

Procaine merethoxylline; theophylline is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:DICURIN PROCAINE · NDA 008869

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
DICURIN PROCAINE	LILLY	NDA 008869	—	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.

Procaine merethoxylline; theophylline — frequently asked questions

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

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