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Data / Drug companies / Nilotinib

Nilotinib: 10 companies and 25 products in the FDA NDC directory

Nilotinib is listed in the FDA National Drug Code Directory by 10 companies, with 25 products in commercial distribution. 15 of the products (60.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; tablet; tablet, orally disintegrating, and the newest product started marketing on June 30, 2026.

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Companies listing it
10
Products
25
Generic (ANDA) products
15 (60.0%)
Application numbers
9
Routes
Oral
Brand names
Tasigna, Danziten, Cavhanza
openFDA record search
api.fda.gov

Companies that list nilotinib

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Apotex Corp.3capsuleGeneric drugs (ANDA)May 23, 2025
Cipla USA Inc.3capsuleNew drug applications (NDA)June 18, 2025
Dr. Reddy's Laboratories Inc.3capsuleGeneric drugs (ANDA)November 19, 2025
Novadoz Pharmaceuticals LLC3capsuleGeneric drugs (ANDA)November 19, 2025
Novartis Pharmaceuticals Corporation3capsuleNew drug applications (NDA)October 29, 2007
AvKARE2capsuleGeneric drugs (ANDA)March 2, 2026
Azurity Pharmaceuticals, Inc.2tabletNew drug applications (NDA)November 30, 2024
Camber Pharmaceuticals, Inc.2capsuleGeneric drugs (ANDA)November 19, 2025
Cycle Pharmaceuticals Ltd2tablet, orally disintegratingNew drug applications (NDA)June 30, 2026
Torrent Pharmaceuticals Limited2capsuleGeneric drugs (ANDA)December 16, 2025

Dosage forms

Dosage formProductsShare
Capsule2184%
Tablet28%
Tablet, orally disintegrating28%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)1560%
New drug applications (NDA)1040%

Pharmacologic classes

ClassProducts
Kinase Inhibitor25

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.