THEOPHYLLINE | A087400 | NOSTRUM PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nostrum Pharmaceuticals, LLC. FDA-2018-P-2104 Nostrum Pharmaceuticals, LLC filed this citizen petition requesting that the FDA amend the Orange Book to designate Alembic Pharmaceutical Ltd.'s Theophylline Extended Release Tablets, 300 mg (ANDA 090430) as an alternate reference standard to facilitate a site transfer of Nostrum's approved Theochr | 505(q) | 2018-06-01 | Withdrawn | Nostrum Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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