Is there a generic for Pemirolast potassium?

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

What is the reference-listed drug for Pemirolast potassium?

ALAMAST (NDA 021079, SANTEN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pemirolast potassium are approved?

Pemirolast potassium is approved in the following dosage form: solution/drops.

FDA Orange Book · active-ingredient family

Pemirolast potassium

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

Reference-listed drug:ALAMAST · NDA 021079

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution/drops

Product	Applicant	Application	TE	Approved
ALAMAST	SANTEN	NDA 021079	—	Sep 24, 1999

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.

Pemirolast potassium — frequently asked questions

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

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