Drug application
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
Drugs@FDA ANDA 215617 · SOMERSET THERAPS LLC
Key facts
| Drug name | PHENYLEPHRINE HYDROCHLORIDE |
|---|---|
| Active ingredients | PHENYLEPHRINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 215617 |
| Company | SOMERSET THERAPS LLC |
| Dosage forms | SOLUTION, INTRAVENOUS |
| Strength | 0.5MG/5ML (0.1MG/ML) |
| Marketing status | Prescription |
| TE codes | AP |
| Reference listed drug | No |
| Latest submission status date | Feb 14, 2025 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- Yes 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: