PSEUDOEPHEDRINE HYDROCHLORIDE | A073585 | MCNEIL CONSUMER HEALTHCARE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Eurand America Inc. FDA-1997-P-0238 · 7 docket documents Eurand America Inc. filed this petition on May 29, 1997, requesting that the FDA permit filing of an ANDA for Pseudoephedrine Hydrochloride 120mg capsules using Sudafed 12 Hour tablets as the reference product under 21 CFR 314.93(b), and requesting that the FDA determine whether the voluntarily with | 505(q) | 2017-05-31 | Partially Denied | Eurand America Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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