Orange Book product
PROMETH FORTIS 25MG/5ML
Orange Book ANDA 084772 · ALPHARMA US PHARMACEUTICALS DIVISION · Discontinued
Key facts
| Proprietary name | PROMETH FORTIS |
|---|---|
| Active ingredients | PROMETHAZINE HYDROCHLORIDE |
| Strength | 25MG/5ML |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA084772 |
| Applicant holder | ALPHARMA US PHARMACEUTICALS DIVISION |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 1, 1982 |
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.