BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | A088811 | PHARMOBEDIENT CONSULTING LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Steranco Healthcare Pvt. Ltd. FDA-2026-P-3202 · 3 docket documents Steranco Healthcare Pvt. Ltd. filed this citizen petition requesting that the FDA determine whether Bromfed-DM Syrup (brompheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride) approved under ANDA 088811 was not withdrawn for safety or effectiveness reasons, as the pr | 505(q) | 2026-03-27 | Open | Steranco Healthcare Pvt. Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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