approval · primary record
PHENYLEPHRINE HYDROCHLORIDE
2 approval events · latest 2025-05-30
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2025-05-30 |
| Approval events | 2 |
| Brand | PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
| Sponsor | DR REDDYS LABS SA |
| Route | INTRAVENOUS |
Approval history
2 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2025-05-30 | FDA | NDA | PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | DR REDDYS LABS SA | INTRAVENOUS |
| 2025-03-13 | FDA | NDA | PHENYLEPHRINE HYDROCHLORIDE | ALCON | OPHTHALMIC |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:29:51.075Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:phenylephrine-hydrochloride
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Phenylephrine Hydrochloride · compound