PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE | N013294 | 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Phenazopyridine Hydrochloride Tablets in 50 mg, 100 mg, and 200 mg strengths are suitable | Other | 2019-12-09 | Withdrawn | Guvam Pharma |
Citizen Petition from Vintage Pharmaceuticals, LLC FDA-2006-P-0136 Vintage Pharmaceuticals, LLC filed this citizen petition on December 1, 2006, requesting that the FDA Commissioner determine whether three drugs—Azo Gantanol (Roche), Azo Gantrisn (Roche), and Sulfamethoxazole, Trimethoprim, and Phenazopyridine HCl (Able)—were voluntarily withdrawn or withheld from | 505(q) | 2008-11-19 | Denied | Vintage Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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