NITROFURANTOIN | N009175 | CASPER PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Macleods Pharmaceuticals Limited FDA-2018-P-0345 Macleods Pharmaceuticals Limited filed this citizen petition under Section 505(j) and 21 CFR 10.25(a), 10.30, and 314.93 requesting that FDA designate Amneal Pharms' approved ANDA #A201679 for Nitrofurantoin Oral Suspension, 25 mg/5 mL as a reference standard or identify a suitable alternative refer | Other | 2018-01-24 | Withdrawn | Macleods Pharmaceuticals Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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