FAMOTIDINE | N020801 | KENVUE BRANDS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Yamanouchi Pharma Technologies Inc. FDA-2000-P-1381 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. |
Attachment 2 - Original Strength Pepcid AC Famotidine Tablets 10mg Acid Reduc... FDA-2023-P-5042 Tenshi Kaizen Private Limited filed a petition requesting FDA evaluation of the regulatory eligibility and suitability of Original Strength Pepcid AC Famotidine Tablets 10mg for over-the-counter use as an acid reducer, seeking confirmation that the product meets the criteria for OTC marketing author | Suitability | 2023-11-15 | Open | Tenshi Kaizen Private Limited |
Attachment 3 - Maximum Strength Pepcid AC Famotidine Tablets 20mg Acid Reduce... FDA-2023-P-5042 Tenshi Kaizen Private Limited filed a petition regarding Maximum Strength Pepcid AC Famotidine Tablets 20mg, an acid reducer product, requesting a determination of regulatory eligibility or suitability status for the formulation. | Suitability | 2023-11-15 | Open | Tenshi Kaizen Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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