Details for New Drug Application (NDA): 202294
NDA 202294 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 ten suppliers. Additional details are available on the DEXLANSOPRAZOLE profile page.
The generic ingredient in DEXLANSOPRAZOLE is dexlansoprazole. There is one drug master file entry 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 is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
Summary for 202294
| Tradename: | DEXLANSOPRAZOLE |
| Applicant: | Ph Health |
| Ingredient: | dexlansoprazole |
| Patents: | 0 |
Pharmacology for NDA: 202294
| Mechanism of Action | Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 202294
Suppliers and Packaging for NDA: 202294
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXLANSOPRAZOLE | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 202294 | ANDA | Par Health USA, LLC | 49884-147 | 49884-147-11 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-147-11) |
| DEXLANSOPRAZOLE | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 202294 | ANDA | Par Health USA, LLC | 49884-148 | 49884-148-09 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 60MG | ||||
| Approval Date: | Apr 19, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Jun 16, 2022 | TE: | AB | RLD: | No | ||||
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