Is there a generic for Aspirin; propoxyphene hydrochloride?

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

What is the reference-listed drug for Aspirin; propoxyphene hydrochloride?

DARVON W/ ASA (NDA 010996, XANODYNE PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Aspirin; propoxyphene hydrochloride are approved?

Aspirin; propoxyphene hydrochloride is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Aspirin; propoxyphene hydrochloride

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

Reference-listed drug:DARVON W/ ASA · NDA 010996

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
DARVON W/ ASA	XANODYNE PHARM	NDA 010996	—	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.

Aspirin; propoxyphene hydrochloride — frequently asked questions

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

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