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General MedicationsOPHTHALMICStandard

CYSTADROPS

CYSTEAMINE HYDROCHLORIDE

Standard Dose
EQ 0.37% BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview CYSTADROPS is listed in Drugs@FDA under application 211302 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CYSTEAMINE HYDROCHLORIDE Form and strength SOLUTION/DROPS;OPHTHALMIC - EQ 0.37% BASE Sponsor RECORDATI RARE Submission history Latest submission status date: 2020-08-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview CYSTADROPS is listed in Drugs@FDA under application 211302 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CYSTEAMINE HYDROCHLORIDE Form and strength SOLUTION/DROPS;OPHTHALMIC - EQ 0.37% BASE Sponsor RECORDATI RARE Submission history Latest submission status date: 2020-08-19 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.