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General MedicationsOPHTHALMICStandard

PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE

Standard Dose
2.5%
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 - 2.5% 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 - 2.5% 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.