Orange Book product
PROMETHAZINE HYDROCHLORIDE 50MG/ML **Federal Register determination that product was…
Orange Book ANDA 040454 · TEVA PHARMACEUTICALS USA · Discontinued
Key facts
| Proprietary name | PROMETHAZINE HYDROCHLORIDE |
|---|---|
| Active ingredients | PROMETHAZINE HYDROCHLORIDE |
| Strength | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA040454 |
| Applicant holder | TEVA PHARMACEUTICALS USA |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 22, 2002 |
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.