CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | A088763 | ACTAVIS MID ATLANTIC LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Background Material re Citizen Petition from Sovereign Pharmaceuticals, Ltd -... FDA-2007-P-0296 This document is an attachment showing Electronic Orange Book listings for Prometh w/ Codeine (Promethazine Hydrochloride and Codeine Phosphate Syrup, 6.25 mg and 10 mg/5 mL), an RX product approved on October 31, 1984, with no unexpired patents or exclusivity listed as of January 2007. The attachme | Other | 2008-05-22 | Withdrawn | Sovereign Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.