AMPHETAMINE | A209253 | ACTAVIS LABORATORIES FL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Exhibit G Final Clinical Study Report Protocol No 381.103 Mixed Salts Ampheta... FDA-2005-P-0120 Shire Pharmaceuticals Group filed a citizen petition requesting FDA review and approval of bioequivalence and bioavailability data for SLI381, a 30 mg mixed salts amphetamine extended-release capsule formulation (IND 58,037). The petition sought to establish that SLI381 administered sprinkled on app | 505(q) | 2012-04-12 | Denied | — |
Exhibit H Final Clinical Study Report Protocol No 381.107 Mixed Salts Ampheta... FDA-2005-P-0120 Shire Pharmaceuticals Group filed a citizen petition in support of a new drug application for SLI381, a mixed salts amphetamine extended-release formulation for attention deficit hyperactivity disorder. The petition included a clinical study demonstrating bioequivalence between a single 40 mg capsul | Other | 2012-04-12 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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