Orange Book product
MICONAZOLE NITRATE 2%
Orange Book ANDA 074366 · COSETTE PHARMACEUTICALS NC LABORATORIES LLC · Discontinued
Key facts
| Proprietary name | MICONAZOLE NITRATE |
|---|---|
| Active ingredients | MICONAZOLE NITRATE |
| Strength | 2% |
| Dosage form | CREAM |
| Route | VAGINAL |
| Application | ANDA074366 |
| Applicant holder | COSETTE PHARMACEUTICALS NC LABORATORIES LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 22, 1996 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.