VALSARTAN | N209139 | CARMEL BIOSCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novitium Pharma LLC FDA-2020-P-0511 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Drug Valsartan (PREXXARTAN) Oral Solution, 20 mg/5 mL, approved under NDA #209139 by Carmel Biosciences Inc., was withdrawn from sale for reasons of s | 505(q) | 2020-01-31 | Denied | Novitium Pharma LLC |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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