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General MedicationsOPHTHALMICStandard

CYCLOMYDRIL

CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

Standard Dose
0.2%;1%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview CYCLOMYDRIL is listed in Drugs@FDA under application 084300 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE Form and strength SOLUTION/DROPS;OPHTHALMIC - 0.2%;1% Sponsor ALCON LABS INC Submission history Latest submission status date: 2025-05-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview CYCLOMYDRIL is listed in Drugs@FDA under application 084300 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE Form and strength SOLUTION/DROPS;OPHTHALMIC - 0.2%;1% Sponsor ALCON LABS INC Submission history Latest submission status date: 2025-05-02 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.