Drug application
DIFELIKEFALIN ACETATE (DIFELIKEFALIN ACETATE)
Drugs@FDA ANDA 220919 · QILU PHARM HAINAN
Key facts
| Drug name | DIFELIKEFALIN ACETATE |
|---|---|
| Active ingredients | DIFELIKEFALIN ACETATE |
| Application type | ANDA |
| Application number | 220919 |
| Company | QILU PHARM HAINAN |
| Dosage forms | SOLUTION, INTRAVENOUS |
| Strength | EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) |
| Marketing status | Prescription |
| TE codes | AP |
| Reference listed drug | No |
| Latest submission status date | Aug 31, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
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.