RecallHawk

DORZOLAMIDE AND TIMOLOL (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION)

FDC LTD

Summary

FDA approved DORZOLAMIDE AND TIMOLOL (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION) by FDC LTD. ANDA (Generic) approval (Labeling) on 2025-05-27. SOLUTION/DROPS, OPHTHALMIC.

Details

Source

Drug Approval

External ID

ANDA205295-12

Action Date

2025-05-27

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

DORZOLAMIDE AND TIMOLOL (generic: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION), SOLUTION/DROPS, OPHTHALMIC. Application: ANDA205295

Company

Context & Analysis

FDC LTD has 5 FDA actions in our database.

Frequently Asked Questions

How often does FDC LTD have FDA actions?

FDC LTD has 5 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 "ANDA205295-12" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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