Is there a generic for Ethchlorvynol?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Ethchlorvynol, referencing the brand PLACIDYL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ethchlorvynol?

PLACIDYL (NDA 010021, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ethchlorvynol are approved?

Ethchlorvynol is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Ethchlorvynol

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

Reference-listed drug:PLACIDYL · NDA 010021

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
PLACIDYL×4	ABBVIE	NDA 010021	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
ETHCHLORVYNOL×4	BANNER PHARMACAPS	ANDA 084463	—	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.

Ethchlorvynol — 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