Details for New Drug Application (NDA): 204629
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NDA 204629 describes JARDIANCE, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from five suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JARDIANCE profile page.
The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.
The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.
Summary for 204629
| Tradename: | JARDIANCE |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | empagliflozin |
| Patents: | 7 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204629
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 204629
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JARDIANCE | empagliflozin | TABLET;ORAL | 204629 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0152 | 0597-0152-07 | 1 BOTTLE in 1 CARTON (0597-0152-07) / 7 TABLET, FILM COATED in 1 BOTTLE |
| JARDIANCE | empagliflozin | TABLET;ORAL | 204629 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0152 | 0597-0152-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0152-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 1, 2014 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Feb 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | LABELING REVISIONS RELATED TO CLINICAL STUDIES | ||||||||
| Regulatory Exclusivity Expiration: | Aug 18, 2024 | ||||||||
| Regulatory Exclusivity Use: | REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE AND REDUCED EJECTION FRACTION | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Apr 3, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2 | ||||||||
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