General MedicationsORALGeneric

CARBIDOPA; LEVODOPA

CARBIDOPA;LEVODOPA

Standard Dose

61.25MG;245MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: None (Tentative Approval)

Summary

Approval overview CARBIDOPA; LEVODOPA is listed in Drugs@FDA under application 208895 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient CARBIDOPA;LEVODOPA Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG Sponsor SANDOZ INC Submission history Latest submission status date: 2023-03-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview CARBIDOPA; LEVODOPA is listed in Drugs@FDA under application 208895 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient CARBIDOPA;LEVODOPA Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG Sponsor SANDOZ INC Submission history Latest submission status date: 2023-03-31 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: None (Tentative Approval)
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.