FDA Orange Book · active-ingredient family
Terbinafine hydrochloride
Terbinafine hydrochloride is approved as 6 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LAMISIL · NDA 022071
6
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, granule, solution, spray, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LAMISILRLD×2 | NOVARTIS | NDA 022071 | — | Sep 28, 2007 | |
| LAMISIL ATRLD×2 | KARO HLTHCARE | NDA 021124 | — | Mar 17, 2000 | |
| LAMISILRLD | KARO HLTHCARE | NDA 020980 | — | Mar 09, 1999 | |
| LAMISILRLD | NOVARTIS | NDA 020539 | — | May 10, 1996 | |
| LAMISIL | KARO HLTHCARE | NDA 020749 | — | Oct 17, 1997 | |
| LAMISIL | NOVARTIS | NDA 020192 | — | Dec 30, 1992 |
Generic (ANDA) products (16)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TERBINAFINE HYDROCHLORIDE | BRECKENRIDGE PHARM | ANDA 077714 | — | Jun 04, 2010 | |
| TERBINAFINE HYDROCHLORIDE | SUN PHARMA CANADA | ANDA 077511 | — | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 078297 | AB | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | CHARTWELL | ANDA 078199 | AB | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | CIPLA | ANDA 077137 | AB | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | EMED MEDCL | ANDA 077919 | AB | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | GEDEON RICHTER USA | ANDA 077065 | — | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | GLENMARK PHARMS LTD | ANDA 078157 | AB | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | HERITAGE PHARMA AVET | ANDA 076377 | — | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | INVAGEN PHARMS | ANDA 077533 | AB | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | MYLAN | ANDA 077136 | — | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | NATCO PHARMA | ANDA 077195 | — | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | ORBION PHARMS | ANDA 078163 | AB | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | ROXANE | ANDA 077223 | — | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | SENORES PHARMS | ANDA 076390 | AB | Jul 02, 2007 | |
| TERBINAFINE HYDROCHLORIDE | WOCKHARDT | ANDA 078229 | — | Jul 02, 2007 |
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.
Terbinafine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
