RecallHawk

ACETAZOLAMIDE (ACETAZOLAMIDE SODIUM)

MYLAN ASI

Summary

FDA approved ACETAZOLAMIDE (ACETAZOLAMIDE SODIUM) by MYLAN ASI. ANDA (Generic) approval (Labeling) on 2026-05-07. INJECTABLE, INJECTION.

Details

Source

Drug Approval

External ID

ANDA200880-15

Action Date

2026-05-07

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

ACETAZOLAMIDE (generic: ACETAZOLAMIDE SODIUM), INJECTABLE, INJECTION. Application: ANDA200880

Company

Context & Analysis

Frequently Asked Questions

How often does MYLAN ASI have FDA actions?

This is the only FDA action we have on record for MYLAN ASI in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "ANDA200880-15" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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