OXYMORPHONE HYDROCHLORIDE | A079087 | IMPAX LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Endo Pharmaceuticals Inc. - Citizen Petition FDA-2012-P-0951 · 5 docket documents Endo Pharmaceuticals Inc. filed this citizen petition under Section 505(q) of the Federal Food, Drug, and Cosmetic Act on August 31, 2012, requesting that the FDA require any ANDA referencing Opana ER CRF (oxymorphone HCl extended-release crush-resistant tablets, approved under NDA No. 201655) to co | 505(q) | 2012-09-26 | Denied | — |
Endo Pharmaceuticals Inc. - Citizen Petition FDA-2012-P-0895 · 12 docket documents Endo Pharmaceuticals Inc. filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine that the discontinued non-crush-resistant version of Opana ER (oxymorphone HCl) extended-release tablets approved under NDA No. 021610 was | 505(q) | 2012-09-11 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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