Drug application
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE)
Drugs@FDA ANDA 218264 · HETERO LABS LTD III
Key facts
| Drug name | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
|---|---|
| Active ingredients | DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 218264 |
| Company | HETERO LABS LTD III |
| Dosage forms | SYRUP, ORAL |
| Strength | 15MG/5ML;6.25MG/5ML |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission status date | Mar 12, 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.