Orange Book product
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 2MG/5ML;10MG/5ML;30MG/5ML
Orange Book ANDA 210647 · ALKEM LABORATORIES LTD · Prescription
Key facts
| Proprietary name | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
|---|---|
| Active ingredients | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Strength | 2MG/5ML;10MG/5ML;30MG/5ML |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA210647 |
| Applicant holder | ALKEM LABORATORIES LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jul 14, 2020 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.