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: 2 brands, 3 generics; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 3 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

PARASAL SODIUM

PANRAYNDA 006811—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—
1GM	TABLET	ORAL	Discontinued	—

TEEBACIN

CONSOLIDATED MIDLANDNDA 007320—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (3)

P.A.S. SODIUM

CENTURY PHARMSANDA 080947—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4GM/PACKET	POWDER	ORAL	Discontinued	—

SODIUM AMINOSALICYLATE

HEXCELANDA 080097—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100%	POWDER	ORAL	Discontinued	—

SODIUM P.A.S.

LANNETTANDA 080138—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Orange Book patent file

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.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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