MECLIZINE HYDROCHLORIDE | A040179 | RISING PHARMA HOLDINGS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Indicus Pharma LLC - Citzen Petition FDA-2012-P-1265 · 4 docket documents Indicus Pharma LLC filed this citizen petition on December 17, 2012, requesting that the FDA amend the Orange Book to designate Mylan Pharms Inc, Par Pharm, and Amneal Pharms as additional reference listed drugs for Meclizine Hydrochloride tablets in all three strengths (12.5 mg, 25 mg, and 50 mg), | 505(q) | 2012-12-31 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.