Is there a generic for Talc?

The FDA Orange Book does not currently list an approved generic (ANDA) for Talc. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Talc?

STERITALC (NDA 205555, NOVATECH SA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Talc are approved?

Talc is approved in the following dosage forms: aerosol, powder.

FDA Orange Book · active-ingredient family

Talc

Talc is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:STERITALC · NDA 205555

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, powder

Product	Applicant	Application	TE	Approved
STERITALCRLD×3	NOVATECH SA	NDA 205555	—	May 01, 2017
TALCRLD	SCIARRA LABS	NDA 021388	—	Dec 15, 2003
SCLEROSOLRLD	SCIARRA LABS	NDA 020587	—	Dec 24, 1997

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.

Talc — frequently asked questions

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

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