TRAZODONE HYDROCHLORIDE | A070491 | USL PHARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 RLD Label for Trazodone Hydrochloride Tablets re: Suitability Pe... FDA-2023-P-4394 Drug Device Consulting LLC filed a citizen petition regarding the suitability of trazodone hydrochloride tablets as a reference listed drug (RLD). The petition appears to address regulatory standards for generic drug approvals under the ANDA process, with the attachment providing labeling informatio | Suitability | 2023-10-10 | Open | Drug Device Consulting LLC |
Attachment 2 Draft Label for Trazodone Hydrochloride Tablets
(75 mg and 25 mg... FDA-2023-P-4394 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 | Open | Drug Device Consulting LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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