Is there a generic for Nedocromil sodium?

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

What is the reference-listed drug for Nedocromil sodium?

ALOCRIL (NDA 021009, ALLERGAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Nedocromil sodium are approved?

Nedocromil sodium is approved in the following dosage forms: aerosol, metered, solution, solution/drops.

FDA Orange Book · active-ingredient family

Nedocromil sodium

Nedocromil sodium is approved as 3 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ALOCRIL · NDA 021009

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, metered, solution, solution/drops

Product	Applicant	Application	TE	Approved
ALOCRILRLD	ALLERGAN	NDA 021009	—	Dec 08, 1999
TILADE	SANOFI AVENTIS US	NDA 020750	—	Oct 01, 1997
TILADE	KING PHARMS LLC	NDA 019660	—	Dec 30, 1992

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
NEDOCROMIL SODIUM	EPIC PHARMA LLC	ANDA 090638	—	Aug 22, 2012

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.

Nedocromil sodium — frequently asked questions

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

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