METFORMIN HYDROCHLORIDE | N021748 | SANTARUS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2019-06-28 | Terminated 2019-09-05 | — | |
Depomed Inc. v. Watson Laboratories Inc. - Florida et al 4 patentsANDA 203755metformin hydrochloride extended release | D. Del. | 2013-02-28 | Terminated 2014-01-07 | — |
Depomed Inc. et al v. Watson Laboratories Inc. Florida et al 2 patentsANDA 203755metformin hydrochloride extended release | D. Del. | 2012-04-18 | Terminated 2014-01-07 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-3798 Senores Pharmaceuticals, Inc. filed this citizen petition under 21 C.F.R. §§ 10.25, 10.30 and sections 505(j) and 505(w) of the FDC Act requesting that FDA determine whether GLUMETZA (metformin hydrochloride extended-release tablets, 500mg and 1g), approved under NDA 021748, was withdrawn from the m | 505(q) | 2026-04-07 | Open | Senores Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.