Is there a generic for Liotrix (t4;t3)?

The FDA Orange Book does not currently list an approved generic (ANDA) for Liotrix (t4;t3). It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Liotrix (t4;t3)?

THYROLAR-0.25 (NDA 016807, ALLERGAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Liotrix (t4;t3) are approved?

Liotrix (t4;t3) is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Liotrix (t4;t3)

Liotrix (t4;t3) is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:THYROLAR-0.25 · NDA 016807

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
THYROLAR-0.25RLD×6	ALLERGAN	NDA 016807	—	Approved Prior to Jan 1, 1982
EUTHROID-0.5×4	PARKE DAVIS	NDA 016680	—	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.

Liotrix (t4;t3) — frequently asked questions

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

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