Is there a generic for Aminosalicylate sodium?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Aminosalicylate sodium, referencing the brand PARASAL SODIUM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Aminosalicylate sodium?

PARASAL SODIUM (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 Aminosalicylate sodium are approved?

Aminosalicylate sodium is approved in the following dosage forms: powder, tablet.

FDA Orange Book · active-ingredient family

Aminosalicylate sodium

Aminosalicylate sodium is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PARASAL SODIUM · NDA 006811

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · powder, tablet

Product	Applicant	Application	TE	Approved
PARASAL SODIUM×2	PANRAY	NDA 006811	—	Approved Prior to Jan 1, 1982
TEEBACIN	CONSOLIDATED MIDLAND	NDA 007320	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
P.A.S. SODIUM	CENTURY PHARMS	ANDA 080947	—	Approved Prior to Jan 1, 1982
SODIUM AMINOSALICYLATE	HEXCEL	ANDA 080097	—	Approved Prior to Jan 1, 1982
SODIUM P.A.S.	LANNETT	ANDA 080138	—	Approved Prior to Jan 1, 1982

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.

Aminosalicylate sodium — frequently asked questions

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

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