General MedicationsORALStandard

TYDEMY

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Standard Dose

3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview TYDEMY is listed in Drugs@FDA under application 205948 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM Form and strength TABLET;ORAL - 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG Sponsor LUPIN LTD Submission history Latest submission status date: 2023-09-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview TYDEMY is listed in Drugs@FDA under application 205948 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM Form and strength TABLET;ORAL - 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG Sponsor LUPIN LTD Submission history Latest submission status date: 2023-09-07 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.