Is there a generic for Aminosalicylic acid?

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

What is the reference-listed drug for Aminosalicylic acid?

PARASAL (NDA 006811, PANRAY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Aminosalicylic acid are approved?

Aminosalicylic acid is approved in the following dosage forms: granule, delayed release, tablet.

FDA Orange Book · active-ingredient family

Aminosalicylic acid

Aminosalicylic acid 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:PARASAL · NDA 006811

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · granule, delayed release, tablet

Product	Applicant	Application	TE	Approved
PARASAL×2	PANRAY	NDA 006811	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
PASER	ADAPTIS	ANDA 074346	—	Jun 30, 1994

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.

Aminosalicylic acid — frequently asked questions

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

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