Is there a generic for Pegaptanib sodium?

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

What is the reference-listed drug for Pegaptanib sodium?

MACUGEN (NDA 021756, BAUSCH AND LOMB INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pegaptanib sodium are approved?

Pegaptanib sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Pegaptanib sodium

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

Reference-listed drug:MACUGEN · NDA 021756

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
MACUGENRLD	BAUSCH AND LOMB INC	NDA 021756	—	Dec 17, 2004

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.

Pegaptanib sodium — frequently asked questions

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

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