Is there a generic for Phenyl aminosalicylate?

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

What is the reference-listed drug for Phenyl aminosalicylate?

PHENY-PAS-TEBAMIN (NDA 011695, PHARM RES ASSOC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Phenyl aminosalicylate are approved?

Phenyl aminosalicylate is approved in the following dosage forms: powder, tablet.

FDA Orange Book · active-ingredient family

Phenyl aminosalicylate

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

Reference-listed drug:PHENY-PAS-TEBAMIN · NDA 011695

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · powder, tablet

Product	Applicant	Application	TE	Approved
PHENY-PAS-TEBAMIN×2	PHARM RES ASSOC	NDA 011695	—	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.

Phenyl aminosalicylate — frequently asked questions

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

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