Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.
HYDROMORPHONE HYDROCHLORIDE | A078439 | LANNETT
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lannett Company, Inc. FDA-2014-P-0196 · 3 docket documents Lannett Company, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that an ANDA may be submitted for Hydromorphone Hydrochloride Tablets at 1 mg strength, which differs from the reference listed | Other | 2014-03-04 | Open | Lannett Company, Inc. |
Citizen Petition From Lannett Company, Inc. FDA-2014-P-0076 · 2 docket documents Lannett Company, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that an ANDA may be submitted for Hydromorphone Hydrochloride Oral Solution at 1 mg per 5 mL, a strength not identical to the re | Other | 2014-01-24 | Open | Lannett Company, Inc. |
Citizen Petition from Lannett Company, Inc. FDA-2013-P-1636 · 3 docket documents Lannett Company, Inc. filed a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA Commissioner determine that Abbreviated New Drug Applications may be submitted for Hydromorphone Hydrochloride Tablets at 1 mg (scored) and | Other | 2014-01-13 | Withdrawn | Lannett Company, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.