AZITHROMYCIN MONOHYDRATE
Summary
FDA approved AZITHROMYCIN MONOHYDRATE by GLAND PHARMA LTD. ANDA (Generic) approval (Labeling) on 2023-03-13. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
ANDA065501-17
Action Date
2023-03-13
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
AZITHROMYCIN MONOHYDRATE, INJECTABLE, INJECTION. Application: ANDA065501
Company
Context & Analysis
GLAND PHARMA LTD has 3 FDA actions in our database.
Frequently Asked Questions
How often does GLAND PHARMA LTD have FDA actions?
GLAND PHARMA LTD has 3 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 "ANDA065501-17" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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