IBUPROFEN | N019012 | KENVUE BRANDS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Actavis Mid-Atlantic LLC - Citizen Petition FDA-2010-P-0145 Actavis Mid-Atlantic LLC filed this citizen petition on March 12, 2010, requesting that the FDA determine that a new dosage form of ibuprofen—Adult Ibuprofen Oral Suspension, 100 mg/5 mL—is suitable for submission as an ANDA using McNeil's Motrin IB Tablets, 200 mg as the reference listed drug under | Other | 2010-03-17 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.