RecallHawk

CARBIDOPA AND LEVODOPA

IMPAX

Summary

FDA approved CARBIDOPA AND LEVODOPA by IMPAX. NDA (New Drug) approval (Labeling) on 2026-03-19. CAPSULE, EXTENDED RELEASE, ORAL.

Details

Source

Drug Approval

External ID

NDA203312-26

Action Date

2026-03-19

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

CARBIDOPA AND LEVODOPA, CAPSULE, EXTENDED RELEASE, ORAL. Application: NDA203312

Company

Context & Analysis

IMPAX has 4 FDA actions in our database.

Frequently Asked Questions

How often does IMPAX have FDA actions?

IMPAX has 4 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA203312-26" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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