Is there a generic for Nisoldipine?

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

What is the reference-listed drug for Nisoldipine?

SULAR (NDA 020356, AZURITY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Nisoldipine are approved?

Nisoldipine is approved in the following dosage form: tablet, extended release.

FDA Orange Book · active-ingredient family

Nisoldipine

Nisoldipine is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SULAR · NDA 020356

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet, extended release

Product	Applicant	Application	TE	Approved
SULARRLD×8	AZURITY	NDA 020356	AB	Jan 02, 2008

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
NISOLDIPINE×2	AMTA	ANDA 216606	AB	Apr 10, 2023
NISOLDIPINE×4	MYLAN	ANDA 091001	—	Jan 26, 2011
NISOLDIPINE×3	MYLAN	ANDA 079051	—	Jul 25, 2008

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.

Nisoldipine — frequently asked questions

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

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