Orange Book product
M-ZOLE 3 COMBINATION PACK 2%,200MG
Orange Book ANDA 074926 · COSETTE PHARMACEUTICALS NC LABORATORIES LLC · Over the counter
Key facts
| Proprietary name | M-ZOLE 3 COMBINATION PACK |
|---|---|
| Active ingredients | MICONAZOLE NITRATE |
| Strength | 2%,200MG |
| Dosage form | CREAM, SUPPOSITORY |
| Route | TOPICAL, VAGINAL |
| Application | ANDA074926 |
| Applicant holder | COSETTE PHARMACEUTICALS NC LABORATORIES LLC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Apr 16, 1999 |
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.