CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Summary
FDA approved CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE by SUN PHARM INDS LTD. ANDA (Generic) approval (Labeling) on 2025-05-20. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA090922-16
Action Date
2025-05-20
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA090922
Company
Context & Analysis
SUN PHARM INDS LTD has 10 FDA actions in our database.
Frequently Asked Questions
How often does SUN PHARM INDS LTD have FDA actions?
SUN PHARM INDS LTD has 10 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 "ANDA090922-16" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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