Is there a generic for Olsalazine sodium?

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

What is the reference-listed drug for Olsalazine sodium?

DIPENTUM (NDA 019715, MYLAN SPCLT VIATRIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Olsalazine sodium are approved?

Olsalazine sodium is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Olsalazine sodium

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

Reference-listed drug:DIPENTUM · NDA 019715

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
DIPENTUMRLD	MYLAN SPCLT VIATRIS	NDA 019715	—	Jul 31, 1990

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.

Olsalazine sodium — frequently asked questions

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

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