Orange Book product · Brand (NDA)
MONISTAT-DERM
MICONAZOLE NITRATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MICONAZOLE NITRATE
Strength
2%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 017494
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2003MONISTAT 3 COMBINATION PACKBrand (NDA)
NDA 021261 · MEDTECH PRODUCTS
- 2001MONISTAT 1 COMBINATION PACKBrand (NDA)
NDA 021308 · MEDTECH PRODUCTS
- 1998MONISTAT 3Brand (NDA)
NDA 020827 · MEDTECH PRODUCTS
- 1996MONISTAT 3 COMBINATION PACKBrand (NDA)
NDA 020670 · MEDTECH PRODUCTS
- 1993MONISTAT 7 COMBINATION PACKBrand (NDA)
NDA 020288 · MEDTECH PRODUCTS
- 1991MONISTAT 7Brand (NDA)
NDA 017450 · MEDTECH PRODUCTS
- 1991MONISTAT 7Brand (NDA)
NDA 018520 · MEDTECH PRODUCTS
- 1989MONISTAT 5Brand (NDA)
NDA 018592 · PERSONAL PRODS
- 1984MONISTAT 3Brand (NDA)
NDA 018888 · MEDTECH PRODUCTS
- —MONISTAT-DERMBrand (NDA)
NDA 017739 · INSIGHT PHARMS
- 2010MICONAZOLE NITRATEGeneric (ANDA)
ANDA 079114 · PERRIGO R AND D
- 2010MICONAZOLE NITRATEGeneric (ANDA)
ANDA 091366 · PERRIGO R AND D
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.
