Treats active duodenal ulcer. ANDA 201695, held by Novel Labs Inc. Famotidine.
As of Nov 15, 2026, ANDA 201695 (Famotidine), held by Novel Labs Inc, was first approved by FDA on Dec 17, 2012, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Famotidine for Oral Suspension is indicated in: Short-term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use Famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year. Short-term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Famotidine40MG/5ML · for suspension;oral | Famotidine | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
