RecallHawk

ATOVAQUONE

GLENMARK SPECLT

Summary

FDA approved ATOVAQUONE by GLENMARK SPECLT. ANDA (Generic) approval (Labeling) on 2026-06-08. SUSPENSION, ORAL.

Details

Source

Drug Approval

External ID

ANDA209685-10

Action Date

2026-06-08

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

ATOVAQUONE, SUSPENSION, ORAL. Application: ANDA209685

Context & Analysis

GLENMARK SPECLT has 8 FDA actions in our database.

Frequently Asked Questions

How often does GLENMARK SPECLT have FDA actions?

GLENMARK SPECLT has 8 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 "ANDA209685-10" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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