PHENOXYBENZAMINE HYDROCHLORIDE | A204522 | PH HEALTH LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Windels Marx Lane & Mittendorf, LLP FDA-2020-P-1771 Windels Marx Lane & Mittendorf, LLP filed this citizen petition requesting that the FDA designate Dextromethorphan Hydrobromide and Promethazine Hydrochloride Oral Syrup (15 mg/5 mL; 6.25 mg/5 mL) approved under ANDA 088864 as a new reference standard in the Orange Book because the current reference | 505(q) | 2020-08-19 | Withdrawn | Windels Marx Lane & Mittendorf, LLP |
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2019-P-1607 Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act on April 2, 2019, requesting that the FDA designate an alternative reference standard for in vivo bioequivalence studies to support its ANDA application for Phenoxybenzamine Hydroc | 505(q) | 2019-04-04 | Granted | Aurobindo Pharma USA, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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