GEMCITABINE HYDROCHLORIDE
Summary
FDA approved GEMCITABINE HYDROCHLORIDE by FRESENIUS KABI USA. ANDA (Generic) approval (Labeling) on 2024-09-24. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
ANDA090242-8
Action Date
2024-09-24
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
GEMCITABINE HYDROCHLORIDE, INJECTABLE, INJECTION. Application: ANDA090242
Company
Context & Analysis
FRESENIUS KABI USA has 70 FDA actions in our database.
Frequently Asked Questions
How often does FRESENIUS KABI USA have FDA actions?
FRESENIUS KABI USA has 70 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 "ANDA090242-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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