FDA Orange Book · active-ingredient family
Terconazole
Terconazole is approved as 4 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TERCONAZOLE · NDA 021735
4
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, suppository
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TERCONAZOLERLD | FOUGERA PHARMS INC | NDA 021735 | BX | Oct 01, 2004 | |
| TERAZOL 3RLD | JANSSEN PHARMS | NDA 019964 | — | Feb 21, 1991 | |
| TERAZOL 3RLD | JANSSEN PHARMS | NDA 019641 | — | May 24, 1988 | |
| TERAZOL 7RLD | JANSSEN PHARMS | NDA 019579 | — | Dec 31, 1987 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TERCONAZOLE | SUN PHARMA CANADA | ANDA 077553 | AB | Mar 09, 2007 | |
| TERCONAZOLE | FOUGERA PHARMS | ANDA 076850 | — | Jul 12, 2006 | |
| TERCONAZOLE | PADAGIS ISRAEL | ANDA 077149 | AB | Mar 17, 2006 | |
| TERCONAZOLE | FOUGERA PHARMS | ANDA 076712 | AB | Feb 18, 2005 | |
| TERCONAZOLE | SUN PHARMA CANADA | ANDA 076043 | AB | Jan 19, 2005 | |
| TERCONAZOLE | SUN PHARMA CANADA | ANDA 075953 | BX | Apr 06, 2004 |
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.
Terconazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
