GUANFACINE HYDROCHLORIDE | N022037 | TAKEDA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2013-11-21 | Terminated 2014-04-07 | — | |
Shire LLC et al v. Mylan Pharmaceuticals Inc. et al 2 patentsANDA 202578guanfacine hydrochloride | WVND | 2011-04-20 | Terminated 2013-03-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-7432 Hyman, Phelps & McNamara, P.C., on behalf of an unnamed client, submitted this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Guanfacine Extended-Release Powder for Oral Suspension, 1 mg/mL, suitable for submission as an Ab | Suitability | 2025-12-31 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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