AMITRIPTYLINE HYDROCHLORIDE | N012703 | ASTRAZENECA PHARMACEUTICALS LP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alembic Pharmaceuticals Limited FDA-2017-P-3581 Alembic Pharmaceuticals Limited filed a citizen petition pursuant to 505(b)(2) and 21 CFR §314.122 requesting that the FDA determine that ELAVIL (amitriptyline hydrochloride tablets, NDA #012703), the reference listed drug manufactured by AstraZeneca Pharmaceuticals LP, was discontinued for reasons | 505(q) | 2017-06-12 | Denied | Alembic Pharmaceuticals Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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