All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-P-3202
Requests that the FDA determine whether Bromfed-DM (Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride) Syrup, 2mg/5mL; 10mg/5mL; 30mg/5mL approved under Abbreviated New Drug Application ("ANDA") number 088811, held by Pharmobedient Consulting LLC, has not been withdrawn for reasons of safety or effectiveness
Documents
3
Comments
0
Description
Open
Key Dates
Comment Period OpensMar 27, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
Steranco Healthcare Pvt. Ltd.
Requests that the FDA determine whether
Bromfed-DM (Brompheniramine Maleate
Dextromethorphan Hydrobromide
Pseudoephedrine Hydrochloride) Syrup,
2mg/5mL; 10mg/5mL; 30mg/5mL approved under
Data from Regulations.gov