Drug application
LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE)
Drugs@FDA ANDA 211528 · APOTEX INC
Key facts
| Drug name | LEVOCETIRIZINE DIHYDROCHLORIDE |
|---|---|
| Active ingredients | LEVOCETIRIZINE DIHYDROCHLORIDE |
| Application type | ANDA |
| Application number | 211528 |
| Company | APOTEX INC |
| Dosage forms | SOLUTION, ORAL |
| Strength | 2.5MG/5ML |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Nov 2, 2018 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No 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: