RecallHawk

CARBAMAZEPINE

APOTEX

Summary

FDA approved CARBAMAZEPINE by APOTEX. ANDA (Generic) approval on 2024-03-08. TABLET, EXTENDED RELEASE, ORAL.

Details

Source

Drug Approval

External ID

ANDA213159-1

Action Date

2024-03-08

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

CARBAMAZEPINE, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA213159

Company

Context & Analysis

APOTEX has 63 FDA actions in our database.

Frequently Asked Questions

How often does APOTEX have FDA actions?

APOTEX has 63 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 "ANDA213159-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for drug

Related Actions