Details for New Drug Application (NDA): 219115
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NDA 219115 describes DEXLANSOPRAZOLE, which is a drug marketed by Alembic, Mylan, Ph Health, and Twi Pharms, and is included in four NDAs. It is available from nine suppliers. Additional details are available on the DEXLANSOPRAZOLE profile page.
The generic ingredient in DEXLANSOPRAZOLE is dexlansoprazole. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
The generic ingredient in DEXLANSOPRAZOLE is dexlansoprazole. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
Summary for 219115
| Tradename: | DEXLANSOPRAZOLE |
| Applicant: | Alembic |
| Ingredient: | dexlansoprazole |
| Patents: | 0 |
Pharmacology for NDA: 219115
| Mechanism of Action | Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 219115
Suppliers and Packaging for NDA: 219115
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXLANSOPRAZOLE | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 219115 | ANDA | Alembic Pharmaceuticals Limited | 46708-823 | 46708-823-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-823-30) |
| DEXLANSOPRAZOLE | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 219115 | ANDA | Alembic Pharmaceuticals Limited | 46708-823 | 46708-823-90 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-823-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Nov 12, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 60MG | ||||
| Approval Date: | Nov 12, 2025 | TE: | AB | RLD: | No | ||||
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