Orange Book product · Brand (NDA)
MONISTAT 1 COMBINATION PACK
MICONAZOLE NITRATE
At a glance
Jun 29, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 29, 2001
25 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
MICONAZOLE NITRATE
Strength
2%,1.2GM
Dosage form
CREAM, INSERT
Route
TOPICAL, VAGINAL
TE code
Not listed
Application
NDA 021308
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2003MONISTAT 3 COMBINATION PACKBrand (NDA)
NDA 021261 · 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
- 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.
