PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Summary
FDA approved PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE by HIKMA. ANDA (Generic) approval (Labeling) on 2025-12-22. SYRUP, ORAL.
Details
Source
Drug Approval
External ID
ANDA040151-28
Action Date
2025-12-22
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, SYRUP, ORAL. Application: ANDA040151
Company
Context & Analysis
HIKMA has 117 FDA actions in our database.
Frequently Asked Questions
How often does HIKMA have FDA actions?
HIKMA has 117 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 "ANDA040151-28" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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