FDA Orange Book · active-ingredient family
Ketoconazole
Ketoconazole is approved as 6 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EXTINA · NDA 021738
6
Brand (NDA)
22
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, foam, cream, gel, shampoo, suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EXTINARLD | RISING | NDA 021738 | — | Jun 12, 2007 | |
| XOLEGELRLD | INA PHARMS | NDA 021946 | — | Jul 28, 2006 | |
| NIZORAL ANTI-DANDRUFFRLD | KRAMER | NDA 020310 | — | Oct 10, 1997 | |
| NIZORALRLD | JANSSEN PHARMS | NDA 019927 | — | Aug 31, 1990 | |
| NIZORALRLD | JANSSEN PHARMA | NDA 019084 | — | Dec 31, 1985 | |
| NIZORALRLD | JANSSEN PHARMS | NDA 018533 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (22)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KETOCONAZOLE | NOVITIUM PHARMA | ANDA 219129 | AB | Jul 03, 2025 | |
| KETOCONAZOLE | ZYDUS LIFESCIENCES | ANDA 218559 | AB | Mar 07, 2025 | |
| KETOCONAZOLE | NOVITIUM PHARMA | ANDA 218498 | AB | Sep 16, 2024 | |
| KETOCONAZOLE | PADAGIS US | ANDA 215185 | — | Nov 17, 2021 | |
| KETOCONAZOLE | XIROMED | ANDA 213601 | AB | May 21, 2021 | |
| KETOCONAZOLE | ENCUBE | ANDA 212443 | AB | May 20, 2021 | |
| KETOCONAZOLE | STRIDES PHARMA | ANDA 210457 | AB | Jun 18, 2018 | |
| KETOCONAZOLE | PADAGIS ISRAEL | ANDA 091550 | AB | Aug 25, 2011 | |
| KETOCONAZOLE | COSETTE PHARMS NC | ANDA 076942 | AB | Apr 11, 2005 | |
| KETOCONAZOLE | FOUGERA PHARMS | ANDA 076294 | AB | Apr 28, 2004 | |
| KETOCONAZOLE | PADAGIS ISRAEL | ANDA 076419 | AB | Jan 07, 2004 | |
| KETOZOLE | SUN PHARMA CANADA | ANDA 075638 | AB | Dec 18, 2002 | |
| KETOCONAZOLE | SENORES PHARMS | ANDA 075912 | AB | Jan 10, 2002 | |
| KETOCONAZOLE | TEVA | ANDA 075581 | AB | Apr 25, 2000 | |
| KETOCONAZOLE | AUROBINDO PHARMA USA | ANDA 075597 | — | Dec 23, 1999 | |
| KETOCONAZOLE | AAIPHARMA LLC | ANDA 075341 | — | Jul 27, 1999 | |
| KETOCONAZOLE | CHARTWELL RX | ANDA 074971 | — | Jun 15, 1999 | |
| KETOCONAZOLE | HERITAGE PHARMA | ANDA 075362 | — | Jun 15, 1999 | |
| KETOCONAZOLE | SUN PHARM INDUSTRIES | ANDA 075314 | — | Jun 15, 1999 | |
| KETOCONAZOLE | TARO | ANDA 075319 | AB | Jun 15, 1999 | |
| KETOCONAZOLE | TEVA | ANDA 075273 | — | Jun 15, 1999 | |
| NIZORAL | JANSSEN PHARMA | ANDA 070767 | — | Nov 07, 1986 |
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.
Ketoconazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
