RecallHawk

TERBINAFINE HYDROCHLORIDE

BRECKENRIDGE PHARM

Summary

FDA approved TERBINAFINE HYDROCHLORIDE by BRECKENRIDGE PHARM. ANDA (Generic) approval (Labeling) on 2024-12-20. TABLET, ORAL.

Details

Source

Drug Approval

External ID

ANDA077714-9

Action Date

2024-12-20

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

TERBINAFINE HYDROCHLORIDE, TABLET, ORAL. Application: ANDA077714

Context & Analysis

BRECKENRIDGE PHARM has 3 FDA actions in our database.

Frequently Asked Questions

How often does BRECKENRIDGE PHARM have FDA actions?

BRECKENRIDGE PHARM has 3 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 "ANDA077714-9" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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