Drug application
ZYCLARA (IMIQUIMOD)
Drugs@FDA NDA 201153 · GRACEWAY
Key facts
| Drug name | ZYCLARA |
|---|---|
| Active ingredients | IMIQUIMOD |
| Application type | NDA |
| Application number | 201153 |
| Company | GRACEWAY |
| Dosage forms | CREAM, TOPICAL |
| Strength | 3.75% |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval |
| Latest submission status date | Mar 24, 2011 |
At a glance
- 1–9 Submissions
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: