RecallHawk

MINOCYCLINE HYDROCHLORIDE

ALKEM LABS LTD

Summary

FDA approved MINOCYCLINE HYDROCHLORIDE by ALKEM LABS LTD. ANDA (Generic) approval (Labeling) on 2025-03-31. TABLET, EXTENDED RELEASE, ORAL.

Details

Source

Drug Approval

External ID

ANDA204453-8

Action Date

2025-03-31

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

MINOCYCLINE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA204453

Context & Analysis

ALKEM LABS LTD has 50 FDA actions in our database.

Frequently Asked Questions

How often does ALKEM LABS LTD have FDA actions?

ALKEM LABS LTD has 50 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 "ANDA204453-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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