Drug application
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE (DIPHENHYDRAMINE HYDROCHLORIDE)
Drugs@FDA ANDA 091526 · FRESENIUS KABI USA
Key facts
| Drug name | DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE |
|---|---|
| Active ingredients | DIPHENHYDRAMINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 091526 |
| Company | FRESENIUS KABI USA |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | 50MG/ML |
| Marketing status | Prescription |
| TE codes | AP |
| Reference listed drug | No |
| Latest submission class | Not Applicable |
| Latest submission status date | Mar 26, 2013 |
At a glance
- 1–9 Submissions
- 1–9 Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- No FDA letters on file
- No 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: