NALOXONE HYDROCHLORIDE | A209522 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Adapt Pharma Operations Lts FDA-2016-P-4094 Adapt Pharma Operations Ltd filed this citizen petition on November 23, 2016, requesting that the FDA not approve any abbreviated new drug application (ANDA) for generic intranasal naloxone products until the agency establishes a product-specific bioequivalence guidance requiring specific pharmacoki | 505(q) | 2016-11-30 | Denied | Adapt Pharma Operations Lts |
Citizen Petition from Adapt Pharma Operations Ltd. FDA-2016-P-3912 Adapt Pharma Operations Ltd filed this citizen petition on November 9, 2016, requesting that the FDA not approve any abbreviated new drug applications (ANDAs) for generic intranasal naloxone products intended for community use until the agency issues formal guidance establishing specific pharmacokin | 505(q) | 2016-11-17 | Withdrawn | Adapt Pharma Operations Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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