VALSARTAN | A214102 | NOVITIUM PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novitium Pharma LLC FDA-2020-P-0511 · 8 docket documents Novitium Pharma LLC filed this relisting petition under 21 C.F.R. §10.25(a) and §10.30 requesting that the FDA determine whether the Reference Listed Drug Valsartan (PREXXARTAN) Oral Solution, 20 mg/5 mL, approved under NDA #209139 by Carmel Biosciences Inc., was withdrawn from sale for reasons of s | 505(q) | 2020-01-31 | Denied | Novitium Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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