Details for New Drug Application (NDA): 208056
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NDA 208056 describes DEXILANT SOLUTAB, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are five patents protecting this drug. Additional details are available on the DEXILANT SOLUTAB profile page.
The generic ingredient in DEXILANT SOLUTAB 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 DEXILANT SOLUTAB 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 208056
| Tradename: | DEXILANT SOLUTAB |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | dexlansoprazole |
| Patents: | 5 |
Medical Subject Heading (MeSH) Categories for 208056
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Jan 26, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 8,461,187*PED | Patent Expiration: | Jul 17, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 8,871,273*PED | Patent Expiration: | Jul 11, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 9,011,926 | Patent Expiration: | Feb 24, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 208056
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | 7,399,485*PED | ⤷ Get Started Free |
| Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | 6,238,994*PED | ⤷ Get Started Free |
| Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | 7,431,942*PED | ⤷ Get Started Free |
| Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | 7,875,292*PED | ⤷ Get Started Free |
| Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | 7,285,668*PED | ⤷ Get Started Free |
| Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | 6,664,276*PED | ⤷ Get Started Free |
| Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | 8,784,885*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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