Application 017450
- Type
- NDA
- Sponsor
- MEDTECH PRODUCTS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | MONISTAT 7 | MICONAZOLE NITRATE | CREAM;VAGINAL | 2% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017450-002 | MONISTAT 7 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | RLD, RS | 1991-02-15 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N017450-002 | MONISTAT 7 | 2% | CREAM / VAGINAL | RLD, RS | 1991-02-15 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N017450-002 | MONISTAT 7 | 2% | CREAM / VAGINAL | RLD, RS | 1991-02-15 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N017450-002 | MONISTAT 7 | 2% | CREAM / VAGINAL | RLD, RS | 1991-02-15 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N017450-002 | MONISTAT 7 | 2% | CREAM / VAGINAL | RLD, RS | 1991-02-15 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Monistat 7 with Reusable Applicator | MICONAZOLE NITRATE | Insight Pharmaceuticals LLC | 2aad40f2-4eea-441d-8b34-5613f1955405 | 2025-10-27 | Warnings | 017450 NDA017450 63736-025 |
| Monistat 7 Combination Pack 7-Day Pre-Filled Applicators | MICONAZOLE NITRATE | Insight Pharmaceuticals LLC | 9b1ac735-9b18-48c2-86dc-93d07157d5e5 | 2025-08-22 | Warnings | 017450 NDA017450 63736-023 |
| MONISTAT 7 7-DAY DISPOSABLE APPLICATORS | MICONAZOLE NITRATE | Insight Pharmaceuticals LLC | c4b68aff-e95f-47ae-b190-6a671bef1877 | 2024-11-12 | Warnings | 017450 NDA017450 63736-026 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63736-003 | Monistat 7 Combination Pack | Miconazole Nitrate | Insight Pharmaceuticals | NDA | Current |
| 63736-023 | Monistat 7 Combination Pack | Miconazole Nitrate | Insight Pharmaceuticals LLC | NDA | Current |
| 63736-023 | Monistat 7 Combination Pack | Miconazole Nitrate | Insight Pharmaceuticals LLC | NDA | Current |
| 63736-025 | Monistat 7 | Miconazole Nitrate | Insight Pharmaceuticals LLC | NDA | Current |
| 63736-025 | Monistat 7 | Miconazole Nitrate | Insight Pharmaceuticals | NDA | Current |
| 63736-026 | MONISTAT 7 | Miconazole Nitrate | Insight Pharmaceuticals LLC | NDA | Current |
| 63736-026 | Monistat 7 | Miconazole Nitrate | Insight Pharmaceuticals | NDA | Current |