General MedicationsORALStandard

CARBIDOPA, LEVODOPA AND ENTACAPONE

CARBIDOPA; ENTACAPONE; LEVODOPA

Standard Dose

31.25MG;200MG;125MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview CARBIDOPA, LEVODOPA AND ENTACAPONE is listed in Drugs@FDA under application 218535 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CARBIDOPA; ENTACAPONE; LEVODOPA Form and strength TABLET;ORAL - 31.25MG;200MG;125MG Sponsor ALEMBIC Submission history Latest submission status date: 2026-02-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview CARBIDOPA, LEVODOPA AND ENTACAPONE is listed in Drugs@FDA under application 218535 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CARBIDOPA; ENTACAPONE; LEVODOPA Form and strength TABLET;ORAL - 31.25MG;200MG;125MG Sponsor ALEMBIC Submission history Latest submission status date: 2026-02-05 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.