Is there a generic for Tromethamine?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Tromethamine, referencing the brand THAM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Tromethamine?

THAM (NDA 013025, HOSPIRA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tromethamine are approved?

Tromethamine is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Tromethamine

Tromethamine is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:THAM · NDA 013025

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
THAMRLD	HOSPIRA	NDA 013025	AP	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
TROMETHAMINE	MILLA PHARMS	ANDA 213116	AP	Dec 31, 2024
TROMETHAMINE	B BRAUN MEDICAL	ANDA 211558	AP	Dec 09, 2024

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.

Tromethamine — frequently asked questions

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

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