Orange Book product
MICONAZOLE NITRATE 2%
Orange Book ANDA 074444 · SUN PHARMA CANADA INC · Over the counter
Key facts
| Proprietary name | MICONAZOLE NITRATE |
|---|---|
| Active ingredients | MICONAZOLE NITRATE |
| Strength | 2% |
| Dosage form | CREAM |
| Route | VAGINAL |
| Application | ANDA074444 |
| Applicant holder | SUN PHARMA CANADA INC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 13, 1997 |
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.