GEMCITABINE HYDROCHLORIDE
Summary
FDA approved GEMCITABINE HYDROCHLORIDE by APOTEX. ANDA (Generic) approval (Labeling) on 2025-09-16. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
ANDA206776-5
Action Date
2025-09-16
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
GEMCITABINE HYDROCHLORIDE, INJECTABLE, INJECTION. Application: ANDA206776
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 "ANDA206776-5" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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