GABAPENTIN
Summary
FDA approved GABAPENTIN by ALKEM. ANDA (Generic) approval (Labeling) on 2026-02-12. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
ANDA090858-42
Action Date
2026-02-12
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
GABAPENTIN, CAPSULE, ORAL. Application: ANDA090858
Company
Context & Analysis
ALKEM has 2 FDA actions in our database.
Frequently Asked Questions
How often does ALKEM have FDA actions?
ALKEM has 2 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 "ANDA090858-42" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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