Is there a generic for Flurbiprofen sodium?

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

What is the reference-listed drug for Flurbiprofen sodium?

OCUFEN (NDA 019404, ALLERGAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Flurbiprofen sodium are approved?

Flurbiprofen sodium is approved in the following dosage form: solution/drops.

FDA Orange Book · active-ingredient family

Flurbiprofen sodium

Flurbiprofen sodium 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:OCUFEN · NDA 019404

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution/drops

Product	Applicant	Application	TE	Approved
OCUFENRLD	ALLERGAN	NDA 019404	—	Dec 31, 1986

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
FLURBIPROFEN SODIUM	BAUSCH AND LOMB	ANDA 074447	—	Jan 04, 1995

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.

Flurbiprofen sodium — frequently asked questions

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

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