Drug application
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
Drugs@FDA ANDA 040454 · TEVA PHARMS USA
Key facts
| Drug name | PROMETHAZINE HYDROCHLORIDE |
|---|---|
| Active ingredients | PROMETHAZINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 040454 |
| Company | TEVA PHARMS USA |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission status date | Aug 22, 2002 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: