OXYCODONE HYDROCHLORIDE | A077290 | NESHER PHARMACEUTICALS USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Actavis Totowa, LLC FDA-2006-P-0279 · 7 docket documents Actavis Totowa, LLC filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Oxycodone Hydrochloride Capsules, 5mg suitable for submission of an ANDA, representing a change in dosage form from the referenced listed drug Oxyco | Suitability | 2008-11-20 | Withdrawn | Actavis Totowa, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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