Is there a generic for Tolbutamide sodium?

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

What is the reference-listed drug for Tolbutamide sodium?

ORINASE DIAGNOSTIC (NDA 012095, PHARMACIA AND UPJOHN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tolbutamide sodium are approved?

Tolbutamide sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Tolbutamide sodium

Tolbutamide sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ORINASE DIAGNOSTIC · NDA 012095

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ORINASE DIAGNOSTIC	PHARMACIA AND UPJOHN	NDA 012095	—	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.

Tolbutamide sodium — frequently asked questions

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

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