HYDROCHLOROTHIAZIDE | A088587 | ROXANE LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P. C. FDA-2022-P-2229 Hyman, Phelps & McNamara, P.C. submitted this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. sections 314.122 and 314.161 requesting that the FDA determine whether Hydrochlorothiazide Oral Solution, 50 mg/5mL, approved under ANDA 088 | 505(q) | 2022-09-13 | Granted | Hyman, Phelps & McNamara, P. C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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