Orange Book product
AMANTADINE HYDROCHLORIDE 50MG/5ML
Orange Book ANDA 073115 · TEVA PHARMACEUTICALS USA · Discontinued
Key facts
| Proprietary name | AMANTADINE HYDROCHLORIDE |
|---|---|
| Active ingredients | AMANTADINE HYDROCHLORIDE |
| Strength | 50MG/5ML |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA073115 |
| Applicant holder | TEVA PHARMACEUTICALS USA |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 23, 1991 |
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.