General MedicationsORALStandard

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Standard Dose

0.5MG;0.4MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE is listed in Drugs@FDA under application 213300 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE Form and strength CAPSULE;ORAL - 0.5MG;0.4MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2024-07-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE is listed in Drugs@FDA under application 213300 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE Form and strength CAPSULE;ORAL - 0.5MG;0.4MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2024-07-18 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.