Drug application
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
Drugs@FDA NDA 216830 · DR REDDYS LABS SA
Key facts
| Drug name | PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
|---|---|
| Active ingredients | PHENYLEPHRINE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 216830 |
| Company | DR REDDYS LABS SA |
| Dosage forms | SOLUTION, INTRAVENOUS |
| Strength | 20MG/250ML (0.08MG/ML) |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | May 30, 2025 |
At a glance
- 1–9 Submissions
- 1–9 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: