RecallHawk

AMABELZ

LUPIN

Summary

FDA approved AMABELZ by LUPIN. ANDA (Generic) approval (Labeling) on 2023-03-15. TABLET, ORAL.

Details

Source

Drug Approval

External ID

ANDA203339-13

Action Date

2023-03-15

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

AMABELZ, TABLET, ORAL. Application: ANDA203339

Company

Context & Analysis

LUPIN has 61 FDA actions in our database.

Frequently Asked Questions

How often does LUPIN have FDA actions?

LUPIN has 61 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 "ANDA203339-13" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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