ROPIVACAINE HYDROCHLORIDE | A078601 | NAVINTA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Navinta LLC - Citizen Petition FDA-2009-P-0601 · 6 docket documents Navinta LLC submitted this citizen petition on December 18, 2009, requesting that the FDA refrain from approving any abbreviated new drug applications (ANDA) for generic ropivacaine hydrochloride monohydrate injection (Naropin) that include a section (viii) statement to U.S. Patent No. 5,670,524 unl | 505(q) | 2010-01-04 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.