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General MedicationsCAPSULE, EXTENDED RELEASEGeneric

CARBIDOPA AND LEVODOPA

CARBIDOPA,LEVODOPA

Standard Dose
23.75MG
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 220119 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient CARBIDOPA,LEVODOPA Form and strength CAPSULE, EXTENDED RELEASE - 23.75MG Sponsor BIOCON PHARMA LIMITED Submission history Latest submission status date: 2025-12-04 00:00:00.

Structured Monograph

Clinical summary

Approval overview CARBIDOPA AND LEVODOPA is listed in Drugs@FDA under application 220119 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient CARBIDOPA,LEVODOPA Form and strength CAPSULE, EXTENDED RELEASE - 23.75MG Sponsor BIOCON PHARMA LIMITED Submission history Latest submission status date: 2025-12-04 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.