HYDROMORPHONE HYDROCHLORIDE | N021217 | SPECGX LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Axinn, Veltrop & Harkrider LLP FDA-2017-P-6219 · 6 docket documents On behalf of a client, attorney Chad A. Landmon of Axinn, Veltrop & Harkrider LLP filed an ANDA suitability petition under Section 505(j)(2)(C) requesting that the FDA declare Hydromorphone HCl extended-release tablets, 24 mg, suitable for submission in an Abbreviated New Drug Application, with Exal | Other | 2017-10-24 | Withdrawn | Axinn, Veltrop & Harkrider LLP |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2013-P-0830 · 4 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Hydromorphone HCI Extended-Release Tablets, 24 mg, suitable for submission in an abbreviated new drug application under Section 505(j)(2)(C), with the reference listed drug being EXALGO Extend | Other | 2013-07-22 | Granted | — |
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.
No patent or exclusivity listings for this strength.