PHENYLEPHRINE HYDROCHLORIDE | N216830 | DR REDDYS LABORATORIES SA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from FDA CDER to Fresenius Kabi USA, LLC FDA-2026-P-1793 Fresenius Kabi USA, LLC filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection at a proposed strength of 40 mg/ | Suitability | 2026-02-19 | Open | FDA CDER to Fresenius Kabi USA |
Suitability Petition from Sagent Pharmaceuticals FDA-2025-P-6893 Sagent Pharmaceuticals filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Phenylephrine Hydrochloride in 0.9% Sodium Chloride injection, 40 mg per 500 mL (0.08 mg/mL), suitable for submission as an ANDA, with the ref | Suitability | 2025-12-10 | Open | Sagent Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 12564561 | Aug 8, 2044 | — | — | Yes | — | — |