HYDROMORPHONE HYDROCHLORIDE | A202144 | ACTAVIS LABORATORIES FL INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
MALLINCKRODT INC. et al v. WATSON LABORATORIES, INC.-FLORIDA. et al 1 patentANDA 202144Hydromorphone Hydrochloride Extended-Release | D.N.J. | 2012-10-25 | Terminated 2013-02-19 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Mallinckrodt Inc. - Citizen Petition FDA-2012-P-0947 · 5 docket documents Mallinckrodt Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any abbreviated new drug application for generic versions of EXALGO (hydromorphone HCl extended-release tablets, 8 mg, 12 mg, 16 mg, and 32 mg) unl | 505(q) | 2012-10-02 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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