METFORMIN HYDROCHLORIDE | A212677 | VISTAPHARM LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
SUN PHARMACEUTICAL INDUSTRIES LTD. et al v. VISTAPHARM, INC. 1 patentANDA 212677metformin hydrochloride | D.N.J. | 2019-03-01 | Terminated 2019-08-22 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Bionpharma, Inc. FDA-2023-P-5687 · 5 docket documents Bionpharma, Inc. filed a citizen petition requesting that the FDA make a determination that RIOMET (Metformin Hydrochloride) Oral Solution, 500 mg/5mL, approved under NDA 021591, was not discontinued or withdrawn from sale for reasons of safety or effectiveness. This determination is necessary to en | 505(q) | 2023-12-27 | Granted | Bionpharma, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4239
per ml
Lowest NADAC/Unit
$0.4239
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 66689031816METFORMIN HCL 500 MG/5 ML SOLN | $0.4239 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.