TRAZODONE HYDROCHLORIDE | N022411 | ANGELINI PHARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 Draft Label for Trazodone Hydrochloride Tablets
(75 mg and 25 mg... FDA-2023-P-4394 · 7 docket documents Drug Device Consulting LLC filed a citizen petition requesting FDA approval of a draft label for Trazodone Hydrochloride Tablets in 25 mg and 75 mg strengths, seeking a determination of suitability for these formulations under the regulatory framework for abbreviated new drug applications or generic | Suitability | 2023-10-10 | Granted | Drug Device Consulting LLC |
Citizen Petition from Kamat Pharmatech FDA-2014-P-0646 · 12 docket documents Kamat Pharmatech filed this suitability petition on June 13, 2014, pursuant to 21 CFR section 314.93 and section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act, requesting FDA approval to submit an abbreviated new drug application for Trazodone Hydrochloride Oral Solution in the strength of | Other | 2014-05-22 | Withdrawn | Kamat Pharmatech |
Source: Regulations.gov. FDA citizen petitions matched by application number.