Orange Book product
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML
Orange Book ANDA 218264 · HETERO LABS LTD UNIT III · Prescription
Key facts
| Proprietary name | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
|---|---|
| Active ingredients | DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE |
| Strength | 15MG/5ML;6.25MG/5ML |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA218264 |
| Applicant holder | HETERO LABS LTD UNIT III |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 12, 2026 |
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.