OXYCODONE HYDROCHLORIDE | N200535 | GENUS LIFE SCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lehigh Valley Technologies, Inc. and Glenmark Generics, Inc. USA (Foley & Lar... FDA-2011-P-0433 Lehigh Valley Technologies, Inc. and Glenmark Generics, Inc. USA filed this citizen petition under sections 505(b), 505(j), and 505(q) of the FD&C Act requesting that the FDA stay approval of any pending ANDAs or 505(b)(2) NDAs for single entity oxycodone hydrochloride products unless the active pha | 505(q) Stay Request | 2011-06-09 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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