METFORMIN HYDROCHLORIDE | N021591 | RANBAXY SIGNATURE 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 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that RIOMET (Metformin Hydrochloride) Oral Solution, 500 mg/5mL, approved under NDA 021591, was not discontinued or withdrawn from sale for reasons of safety or effectiveness.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 | Denied | Bionpharma |
Citizen Petition from Oryza Pharmaceuticals Inc. FDA-2023-P-0884 Oryza Pharmaceuticals Inc. filed this citizen petition under Section 505(i) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether the Reference Listed Drug RIOMET (metformin hydrochloride) Oral Solution, 500mg/5mL under NDA 021591 held by Ranbaxy Signature LLC was vol | 505(q) | 2023-03-10 | Granted | Oryza Pharmaceuticals Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.