LOPERAMIDE HYDROCHLORIDE | N019860 | KENVUE BRANDS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizens Petition from Banner Pharmacaps Inc. FDA-2002-P-0134 · 4 docket documents Banner Pharmacaps Inc. filed this citizen petition on August 5, 2002, requesting that the FDA permit the filing of an Abbreviated New Drug Application for Loperamide Hydrochloride 2 mg soft gelatin capsules, which differs in dosage form from the Reference Listed Drug Imodium A-D tablets, pursuant to | Other | 2009-11-17 | Withdrawn | Banner Pharmacaps Inc. |
Citizens Petition from Banner Pharmacaps Inc. FDA-2002-P-0076 · 8 docket documents Banner Pharmacaps Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA permit submission of an Abbreviated New Drug Application for Loperamide Hydrochloride 1 mg soft gelatin capsules, which would differ in strength and dosag | Other | 2009-11-17 | Granted | Banner Pharmacaps Inc. |
Citizen Petition from AAC Consulting Group FDA-2006-P-0397 · 6 docket documents The document provided does not contain a citizen petition from AAC Consulting Group. Instead, it consists of FDA Orange Book excerpts from 2006 listing approved drug products, including insulin formulations, ketoconazole, ketoprofen, and loperamide hydrochloride products, along with patent and exclu | Other | 2009-04-01 | Open | AAC Consulting Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.