IBUPROFEN | N018197 | BASF CORP
| 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 | — |
Sidmak Laboratories, Inc - Citizen Petition FDA-1987-P-0230 Sidmak Laboratories, Inc. filed this citizen petition under section 505(j)(2)(c) of the Food Drug and Cosmetic Act on July 6, 1987, requesting that the FDA approve the filing of an abbreviated new drug application (ANDA) for ibuprofen 200mg in soft gelatin capsule form, which would be bioequivalent | Other | 2009-12-23 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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