FAMOTIDINE | N020325 | KENVUE BRANDS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Yamanouchi Pharma Technologies Inc. FDA-2000-P-1381 · 5 docket documents Yamanouchi Pharma Technologies Inc. filed this suitability petition pursuant to 21 CFR 314.93 requesting permission to file an Abbreviated New Drug Application for Famotidine Orally Disintegrating Tablets 10 mg, an over-the-counter product that differs from the reference listed drug Pepcid AC Tablet | Other | 2024-01-04 | Granted | Yamanouchi Pharma Technologies Inc. |
Suitability Petition from Tenshi Kaizen Private Limited FDA-2023-P-5042 · 10 docket documents Tenshi Kaizen Private Limited submitted this suitability petition on November 14, 2023, pursuant to Section 505(j)(2)(C) of the FD&C Act and 21 C.F.R. § 314.93, requesting that FDA determine Famotidine Orally Disintegrating Tablets in 10 mg and 20 mg strengths suitable for submission as an ANDA, wit | Suitability | 2023-11-15 | Withdrawn | Tenshi Kaizen Private Limited |
Citizen Petition from Tenshi Kaizen Private Limited FDA-2020-P-1728 · 7 docket documents Tenshi Kaizen Private Limited filed this citizen petition on August 3, 2020 pursuant to Section 505(j)(2)(C) of the FD&C Act requesting that the FDA determine that Famotidine Orally Disintegrating Tablets, 20 mg (OTC), is suitable for submission as an ANDA, with the Reference Listed Drug being Pepci | Other | 2020-08-04 | Withdrawn | Tenshi Kaizen Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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