BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUD...
Summary
FDA approved BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) by ACELLA. ANDA (Generic) approval (Labeling) on 2022-10-27. SYRUP, ORAL.
Details
Source
Drug Approval
External ID
ANDA203375-5
Action Date
2022-10-27
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE (generic: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE), SYRUP, ORAL. Application: ANDA203375
Company
Context & Analysis
Frequently Asked Questions
How often does ACELLA have FDA actions?
This is the only FDA action we have on record for ACELLA in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "ANDA203375-5" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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