Orange Book product
PROMETH W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML **Federal Register determination that…
Orange Book ANDA 088762 · G AND W LABORATORIES INC · Discontinued
Key facts
| Proprietary name | PROMETH W/ DEXTROMETHORPHAN |
|---|---|
| Active ingredients | DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE |
| Strength | 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA088762 |
| Applicant holder | G AND W LABORATORIES INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Oct 31, 1984 |
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.