PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE | N019358 | HOFFMANN LA ROCHE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Guvam Pharma, LLC FDA-2019-P-5791 Guvam Pharma LLC filed this ANDA Suitability Petition on December 6, 2019, pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA determine Phenazopyridine Hydrochloride Tablets in 50 mg, 100 mg, and 200 mg strengths are suitable | Other | 2019-12-09 | Withdrawn | Guvam Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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