General MedicationsOPHTHALMICStandard

PHENYLEPHRINE HYDROCHLORIDE

Standard Dose

10%

Max Dose

Refer to approved labeling

Primary Use

Review priority: UNKNOWN Marketing status: Prescription

Summary

Approval overview PHENYLEPHRINE HYDROCHLORIDE is listed in Drugs@FDA under application 218129 (ANDA).

Review priority: UNKNOWN Marketing status: Prescription Active ingredient PHENYLEPHRINE HYDROCHLORIDE Form and strength SOLUTION/DROPS;OPHTHALMIC - 10% Sponsor GLAND Submission history Latest submission status date: 2025-09-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview PHENYLEPHRINE HYDROCHLORIDE is listed in Drugs@FDA under application 218129 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient PHENYLEPHRINE HYDROCHLORIDE Form and strength SOLUTION/DROPS;OPHTHALMIC - 10% Sponsor GLAND Submission history Latest submission status date: 2025-09-17 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: UNKNOWN

Interaction Notes

No interaction notes stored yet.