TRAMADOL HYDROCHLORIDE | N021692 | VALEANT PHARMACEUTICALS NORTH AMERICA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Services, Inc - Citizen Petition FDA-2009-P-0429 · 6 docket documents Lachman Consultant Services, Inc. filed this petition under Section 505(b)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Tramadol Hydrochloride and Acetaminophen Tablets, 75 mg/650 mg suitable for consideration in an abbreviated new drug application (ANDA), based o | Other | 2009-09-13 | Withdrawn | — |
Citizen Petition from Perdue Pharma LP FDA-2007-P-0186 · 8 docket documents Purdue Pharma LP filed this citizen petition on March 13, 2007, requesting that the FDA refuse approval of Cipher Pharmaceuticals' NDA for CIP-TRAMADOL ER, a 24-hour extended-release tramadol formulation, unless Cipher either provides appropriate patent certification regarding U.S. Patent No. 6,254, | 505(q) | 2008-05-06 | Denied | Perdue Pharma LP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.