FDA Orange Book · active-ingredient family
Miconazole nitrate
Miconazole nitrate is approved as 11 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MONISTAT 3 COMBINATION PACK · NDA 021261
11
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, cream, insert, cream, suppository, lotion, suppository, tampon
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MONISTAT 3 COMBINATION PACKRLD×2 | MEDTECH PRODUCTS | NDA 021261 | — | Jun 17, 2003 | |
| MONISTAT 1 COMBINATION PACKRLD | MEDTECH PRODUCTS | NDA 021308 | — | Jun 29, 2001 | |
| MONISTAT 3RLD | MEDTECH PRODUCTS | NDA 020827 | — | Mar 30, 1998 | |
| MONISTAT 3 COMBINATION PACKRLD | MEDTECH PRODUCTS | NDA 020670 | — | Apr 16, 1996 | |
| MONISTAT 7 COMBINATION PACKRLD | MEDTECH PRODUCTS | NDA 020288 | — | Apr 26, 1993 | |
| MONISTAT 7RLD | MEDTECH PRODUCTS | NDA 017450 | — | Feb 15, 1991 | |
| MONISTAT 7RLD | MEDTECH PRODUCTS | NDA 018520 | — | Feb 15, 1991 | |
| MONISTAT 3RLD | MEDTECH PRODUCTS | NDA 018888 | AB | Aug 15, 1984 | |
| MONISTAT 5 | PERSONAL PRODS | NDA 018592 | — | Oct 27, 1989 | |
| MONISTAT-DERM | INSIGHT PHARMS | NDA 017494 | — | Approved Prior to Jan 1, 1982 | |
| MONISTAT-DERM | INSIGHT PHARMS | NDA 017739 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MICONAZOLE NITRATE | PERRIGO R AND D | ANDA 079114 | — | Jun 02, 2010 | |
| MICONAZOLE NITRATE | PERRIGO R AND D | ANDA 091366 | — | Jan 15, 2010 | |
| MICONAZOLE 3 | SUN PHARMA CANADA | ANDA 076773 | — | Mar 02, 2005 | |
| MICONAZOLE 3 COMBINATION PACK | PERRIGO | ANDA 076357 | — | Mar 30, 2004 | |
| MICONAZOLE 7 COMBINATION PACK | COSETTE | ANDA 076585 | — | Mar 26, 2004 | |
| MICONAZOLE NITRATE COMBINATION PACK | L PERRIGO CO | ANDA 075329 | — | Apr 20, 1999 | |
| M-ZOLE 3 COMBINATION PACK | COSETTE PHARMS NC | ANDA 074926 | — | Apr 16, 1999 | |
| M-ZOLE 7 DUAL PACK | ACTAVIS MID ATLANTIC | ANDA 074586 | — | Jul 17, 1997 | |
| MICONAZOLE NITRATE | PERRIGO | ANDA 074760 | — | May 15, 1997 | |
| MICONAZOLE NITRATE | COSETTE | ANDA 074414 | — | Apr 30, 1997 | |
| MICONAZOLE NITRATE | PERRIGO | ANDA 074395 | — | Mar 20, 1997 | |
| MICONAZOLE NITRATE | SUN PHARMA CANADA | ANDA 074444 | — | Jan 13, 1997 | |
| MICONAZOLE 7 | ENCUBE | ANDA 074164 | — | Mar 29, 1996 | |
| MICONAZOLE NITRATE | COSETTE | ANDA 074366 | — | Feb 22, 1996 | |
| MICONAZOLE NITRATE | TEVA | ANDA 074136 | — | Jan 04, 1995 | |
| MICONAZOLE NITRATE | ACTAVIS PHARMA | ANDA 073508 | AB | Nov 19, 1993 | |
| MICONAZOLE NITRATE | COSETTE PHARMS NC | ANDA 073507 | — | Nov 19, 1993 | |
| MICONAZOLE NITRATE | TEVA PHARMS | ANDA 074030 | — | Oct 30, 1992 |
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.
Miconazole nitrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
