General MedicationsCAPSULE, EXTENDED RELEASEGeneric
CARBIDOPA AND LEVODOPA
CARBIDOPA, LEVODOPA
Standard Dose
95MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview CARBIDOPA AND LEVODOPA is listed in Drugs@FDA under application 219231 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient CARBIDOPA, LEVODOPA Form and strength CAPSULE, EXTENDED RELEASE - 95MG Sponsor DR REDDYS LABS LTD Submission history Latest submission status date: 2025-06-13 00:00:00.
Structured Monograph
Clinical summary
Approval overview CARBIDOPA AND LEVODOPA is listed in Drugs@FDA under application 219231 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient CARBIDOPA, LEVODOPA Form and strength CAPSULE, EXTENDED RELEASE - 95MG Sponsor DR REDDYS LABS LTD Submission history Latest submission status date: 2025-06-13 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.