dexlansoprazole
Drug Details
- Generic Name
- dexlansoprazole
- Brand Names
- Dexlansoprazole delayed release, Dexlansoprazole, Dexilant
- Application Number
- ANDA202666
- Sponsor
- Jubilant Biosys limited
- NDC Codes
- 15
- Dosage Forms
- POWDER, CAPSULE, DELAYED RELEASE, CAPSULE, DELAYED RELEASE PELLETS
- Routes
- ORAL
- Active Ingredients
- DEXLANSOPRAZOLE, DEXLANSOPRAZOLE SESQUIHYDRATE
Indications and Usage
1 INDICATIONS AND USAGE Dexlansoprazole delayed-release capsules are proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). ( 1.1 ) Maintenance of healed EE and relief of heartburn. ( 1.2 ) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). ( 1.3 ) 1.1 Healing of Erosive Esophagitis Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. 1.2 Maintenance of Healed Erosive Esophagitis and Relief of Heartburn Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. 1.3 Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.