GEMCITABINE HYDROCHLORIDE
Summary
FDA approved GEMCITABINE HYDROCHLORIDE by INGENUS PHARMS LLC. ANDA (Generic) approval (Labeling) on 2025-07-09. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
ANDA210383-5
Action Date
2025-07-09
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
GEMCITABINE HYDROCHLORIDE, INJECTABLE, INJECTION. Application: ANDA210383
Company
Context & Analysis
INGENUS PHARMS LLC has 12 FDA actions in our database.
Frequently Asked Questions
How often does INGENUS PHARMS LLC have FDA actions?
INGENUS PHARMS LLC has 12 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 "ANDA210383-5" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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