Orange Book product
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 2MG/5ML;10MG/5ML;30MG/5ML
Orange Book ANDA 205292 · PADAGIS US LLC · 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 | ANDA205292 |
| Applicant holder | PADAGIS US LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Jul 15, 2014 |
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.