General MedicationsORALStandard

SAPROPTERIN DIHYDROCHLORIDE

Standard Dose

100MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview SAPROPTERIN DIHYDROCHLORIDE is listed in Drugs@FDA under application 218797 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SAPROPTERIN DIHYDROCHLORIDE Form and strength TABLET;ORAL - 100MG Sponsor ZENARA Submission history Latest submission status date: 2025-06-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview SAPROPTERIN DIHYDROCHLORIDE is listed in Drugs@FDA under application 218797 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SAPROPTERIN DIHYDROCHLORIDE Form and strength TABLET;ORAL - 100MG Sponsor ZENARA Submission history Latest submission status date: 2025-06-11 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.