Orange Book product
BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE 12.5MG/5ML;10MG/5ML
Orange Book ANDA 088626 · WOCKHARDT EU OPERATIONS (SWISS) AG · Discontinued
Key facts
| Proprietary name | BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
|---|---|
| Active ingredients | BROMODIPHENHYDRAMINE HYDROCHLORIDE, CODEINE PHOSPHATE |
| Strength | 12.5MG/5ML;10MG/5ML |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA088626 |
| Applicant holder | WOCKHARDT EU OPERATIONS (SWISS) AG |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Oct 12, 1984 |
At a glance
- None 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.