NAPROXEN | A074190 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novitium Pharma LLC FDA-2017-P-6689 Novitium Pharma LLC, a specialty pharmaceutical company developing generic drugs, submitted a citizen petition pursuant to 21 CFR 10.25(a), 10.30, and 314.122 requesting that the FDA designate West Ward Pharmaceuticals International Limited's approved generic Naproxen Oral Suspension 25 mg/mL (ANDA | 505(q) | 2017-11-30 | Denied | Novitium Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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