Is there a generic for Pyrithione zinc?

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

What is the reference-listed drug for Pyrithione zinc?

HEAD & SHOULDERS CONDITIONER (NDA 019412, WARNER CHILCOTT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pyrithione zinc are approved?

Pyrithione zinc is approved in the following dosage form: lotion.

FDA Orange Book · active-ingredient family

Pyrithione zinc

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

Reference-listed drug:HEAD & SHOULDERS CONDITIONER · NDA 019412

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · lotion

Product	Applicant	Application	TE	Approved
HEAD & SHOULDERS CONDITIONER	WARNER CHILCOTT	NDA 019412	—	Mar 10, 1986

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.

Pyrithione zinc — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo