Drug application
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE)
Drugs@FDA ANDA 210647 · ALKEM LABS LTD
Key facts
| Drug name | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
|---|---|
| Active ingredients | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 210647 |
| Company | ALKEM LABS LTD |
| Dosage forms | SYRUP, ORAL |
| Strength | 2MG/5ML;10MG/5ML;30MG/5ML |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission status date | Jul 14, 2020 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 10–99 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.