NITROFURANTOIN | N009175 | CASPER PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2020-P-2132 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA designate ANDA 201355 for Nitrofurantoin Oral Suspension, 25 mg/5 mL as a new reference standard in the Orange Book, because the current reference standard approved under NDA 009175 is commercially unavailable and pre | 505(q) | 2020-10-27 | Withdrawn | HYMAN, PHELPS & MCNAMARA, P.C. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2019-P-4879 · 5 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA designate Nitrofurantoin Oral Suspension 25 mg/5 mL marketed by Nostrum Laboratories Inc. under ANDA 201355 as the new Reference Standard product, because the current reference standard Furadantin (nitrofurantoin) Oral Sus | 505(q) | 2019-10-18 | Withdrawn | Lachman Consultant Services, Inc. |
Citizen Petition from Macleods Pharmaceuticals Limited FDA-2018-P-0345 · 9 docket documents 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Oral Suspension, 25 mg/5 mL as a reference standard or identify a suitable alternative refer | Other | 2018-01-24 | Withdrawn | Macleods Pharmaceuticals Limited |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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