Is there a generic for Monoctanoin?

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

What is the reference-listed drug for Monoctanoin?

MOCTANIN (NDA 019368, ETHITEK) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Monoctanoin are approved?

Monoctanoin is approved in the following dosage form: liquid.

FDA Orange Book · active-ingredient family

Monoctanoin

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

Reference-listed drug:MOCTANIN · NDA 019368

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · liquid

Product	Applicant	Application	TE	Approved
MOCTANIN	ETHITEK	NDA 019368	—	Oct 29, 1985

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.

Monoctanoin — frequently asked questions

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

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