Details for New Drug Application (NDA): 208026
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NDA 208026 describes JENTADUETO XR, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JENTADUETO XR profile page.
The generic ingredient in JENTADUETO XR is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.
The generic ingredient in JENTADUETO XR is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.
Summary for 208026
| Tradename: | JENTADUETO XR |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | linagliptin; metformin hydrochloride |
| Patents: | 9 |
Pharmacology for NDA: 208026
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 208026
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0270 | 0597-0270-12 | 1 BOTTLE in 1 CARTON (0597-0270-12) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0270 | 0597-0270-73 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-73) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG;1GM | ||||
| Approval Date: | May 27, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Oct 2, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 208026
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