ZOLPIDEM TARTRATE
Summary
FDA approved ZOLPIDEM TARTRATE by BRECKENRIDGE. ANDA (Generic) approval (Labeling) on 2022-11-21. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA213592-3
Action Date
2022-11-21
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
ZOLPIDEM TARTRATE, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA213592
Company
Context & Analysis
BRECKENRIDGE has 8 FDA actions in our database.
Frequently Asked Questions
How often does BRECKENRIDGE have FDA actions?
BRECKENRIDGE has 8 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 "ANDA213592-3" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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