Details for New Drug Application (NDA): 022287
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The generic ingredient in DEXILANT is dexlansoprazole. There are seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
Summary for 022287
Tradename: | DEXILANT |
Applicant: | Takeda Pharms Usa |
Ingredient: | dexlansoprazole |
Patents: | 10 |
Pharmacology for NDA: 022287
Mechanism of Action | Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 022287
Suppliers and Packaging for NDA: 022287
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287 | NDA AUTHORIZED GENERIC | TWI PHARMACEUTICALS, INC. | 24979-703 | 24979-703-06 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-703-06) |
DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287 | NDA AUTHORIZED GENERIC | TWI PHARMACEUTICALS, INC. | 24979-704 | 24979-704-06 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-704-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Jan 30, 2009 | TE: | AB | RLD: | Yes | ||||
Patent: | 7,790,755*PED | Patent Expiration: | Feb 2, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | 8,105,626*PED | Patent Expiration: | Mar 27, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | 8,173,158*PED | Patent Expiration: | Sep 17, 2030 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 022287
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-001 | Jan 30, 2009 | 9,145,389 | ⤷ Subscribe |
Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-002 | Jan 30, 2009 | 5,433,959*PED | ⤷ Subscribe |
Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-001 | Jan 30, 2009 | 6,664,276*PED | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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