Is there a generic for Molindone hydrochloride?

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

What is the reference-listed drug for Molindone hydrochloride?

MOBAN (NDA 017111, CHARTWELL RX) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Molindone hydrochloride are approved?

Molindone hydrochloride is approved in the following dosage forms: capsule, concentrate, tablet.

FDA Orange Book · active-ingredient family

Molindone hydrochloride

Molindone hydrochloride is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MOBAN · NDA 017111

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, concentrate, tablet

Product	Applicant	Application	TE	Approved
MOBANRLD×8	CHARTWELL RX	NDA 017111	—	Approved Prior to Jan 1, 1982
MOBAN	ENDO PHARMS	NDA 017938	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
MOLINDONE HYDROCHLORIDE×3	EPIC PHARMA LLC	ANDA 090453	—	Mar 20, 2015

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.

Molindone hydrochloride — frequently asked questions

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

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