MESALAMINE | A076751 | PADAGIS ISRAEL PHARMACEUTICALS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novitium Pharma LLC FDA-2020-P-1775 · 3 docket documents Novitium Pharma LLC submitted this citizen petition on August 19, 2020 under 21 C.F.R. § 10.30 requesting that the FDA designate the generic product Mesalamine Enema 4 g/60 mL manufactured by Perrigo Israel Pharmaceuticals Ltd (ANDA #076751) as a reference standard because the original reference lis | Other | 2020-08-19 | WithdrawnUnverified summary | Novitium Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$135.19
per ea
Lowest NADAC/Unit
$0.0974
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 45802092341MESALAMINE 4 GM/60 ML KIT | $135.19 | EA | Generic | — | 2026-08-19 |
| 45802092949MESALAMINE 4 GM/60 ML KIT | $135.19 | EA | Generic | — | 2026-08-19 |
| 45802009828MESALAMINE 4 GM/60 ML ENEMA | $0.1789 | ML | Generic | — | 2026-08-19 |
| 45802009851MESALAMINE 4 GM/60 ML ENEMA | $0.0974 | ML | Generic | — | 2026-08-19 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.