Sold as Monistat 7, Monistat-Derm, Monistat 5, Monistat 3, Monistat 7 Combination Pack and 3 more. Every FDA application for this active ingredient: 12 branded and 18 generic.
As of Nov 15, 2026, FDA lists 30 applications for Miconazole Nitrate (sold as Monistat 7, Monistat-Derm, Monistat 5 and others), first approved Jan 8, 1974, with 4 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Miconazole 3 | Part D | $158K | +15% | 2,727 |
| Jan 8, 1974 | Monistat-DermNDA 17494 · New formulation or manufacturer | Insight Pharms | 23 | Discontinued |
| Jan 30, 1974 | Monistat 7NDA 17450 · New molecular entity | Medtech Products | 53 | Marketed |
| Mar 15, 1982 | Monistat 7NDA 18520 · New dosage form | Medtech Products | 15 | Marketed |
| Aug 15, 1984 | Monistat 3NDA 18888 · New formulation or manufacturer | Medtech Products | 12 | Marketed |
| Oct 27, 1989 | Monistat 5NDA 18592 · New dosage form | Personal Prods | 0 | Discontinued |
| Oct 30, 1992 | Miconazole NitrateANDA 74030 | Teva Pharms | 11 | Discontinued |
| Apr 26, 1993 | Monistat 7 Combination PackNDA 20288 · New dosage form | Medtech Products | 9 | Marketed |
| Nov 19, 1993 | Miconazole NitrateANDA 73507 | Cosette Pharms Nc | 15 | Marketed |
| Nov 19, 1993 | Miconazole NitrateANDA 73508 | Actavis Pharma | 12 | Marketed |
| Jan 4, 1995 | Miconazole NitrateANDA 74136 | Teva | 8 | Discontinued |
| Feb 22, 1996 | Miconazole NitrateANDA 74366 | Cosette Pharms Nc | 5 | Discontinued |
| Mar 29, 1996 | Miconazole 7ANDA 74164 | Encube | 13 | Marketed |
| Apr 16, 1996 | Monistat 3 Combination PackNDA 20670 · TYPE 8 | Medtech Products | 18 | Marketed |
| Jan 13, 1997 | Miconazole NitrateANDA 74444 | Sun Pharma Canada | 10 | Marketed |
| Mar 20, 1997 | Miconazole NitrateANDA 74395 | Perrigo | 3 | Discontinued |
| Apr 30, 1997 | Miconazole NitrateANDA 74414 | Cosette Pharms Nc | 3 | Discontinued |
| May 15, 1997 | Miconazole NitrateANDA 74760 | Perrigo | 7 | Marketed |
| Jul 17, 1997 | M-Zole 7 Dual PackANDA 74586 | Actavis Mid Atlantic | 6 | Discontinued |
| Mar 30, 1998 | Monistat 3NDA 20827 · New dosage form | Medtech Products | 18 | Marketed |
| Apr 16, 1999 | M-Zole 3 Combination PackANDA 74926 | Cosette Pharms Nc | 7 | Marketed |
| Apr 20, 1999 | Miconazole Nitrate Combination PackANDA 75329 | L Perrigo Co | 7 | Marketed |
| Jun 30, 1999 | Monistat Dual- PakNDA 20968 · New dosage form | Personal Prods | 3 | Discontinued |
| Feb 2, 2001 | Monistat 3 Combination PackNDA 21261 · New combination | Medtech Products | 13 | Marketed |
| Jun 29, 2001 | Monistat 1 Combination PackNDA 21308 · New dosage form | Medtech Products | 14 | Marketed |
| Mar 26, 2004 | Miconazole 7 Combination PackANDA 76585 | Cosette Pharms Nc | 0 | Discontinued |
| Mar 30, 2004 | Miconazole 3 Combination PackANDA 76357 | Perrigo | 2 | Marketed |
| Mar 2, 2005 | Miconazole 3ANDA 76773 | Sun Pharma Canada | 0 | Marketed |
| Jan 15, 2010 | Miconazole NitrateANDA 91366 | Perrigo R And D | 1 | Marketed |
| Jun 2, 2010 | Miconazole NitrateANDA 79114 | Perrigo R And D | 2 | Marketed |
| — | Monistat-DermNDA 17739 | Insight Pharms | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Teva
Sun Pharma Canada
Perrigo