Orange Book product · Generic (ANDA)
MICONAZOLE 3
MICONAZOLE NITRATE
At a glance
Mar 02, 2005
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 02, 2005
21 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
MICONAZOLE NITRATE
Strength
4%
Dosage form
CREAM
Route
VAGINAL
TE code
Not listed
Application
ANDA 076773
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MICONAZOLE NITRATE
- 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 017494 · INSIGHT PHARMS
- —MONISTAT-DERMBrand (NDA)
NDA 017739 · INSIGHT PHARMS
- 2010MICONAZOLE NITRATEGeneric (ANDA)
ANDA 079114 · 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.
