Is there a generic for Pentazocine lactate?

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

What is the reference-listed drug for Pentazocine lactate?

TALWIN (NDA 016194, HOSPIRA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pentazocine lactate are approved?

Pentazocine lactate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Pentazocine lactate

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

Reference-listed drug:TALWIN · NDA 016194

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
TALWINRLD	HOSPIRA	NDA 016194	—	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.

Pentazocine lactate — frequently asked questions

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

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