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Details for New Drug Application (NDA): 204629
NDA 204629 describes JARDIANCE, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the JARDIANCE profile page.
The generic ingredient in JARDIANCE is empagliflozin. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.
The generic ingredient in JARDIANCE is empagliflozin. There are fourteen drug master file entries for this compound. Two 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: | 3 |
| 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 | N | 0597-0152-30 |
| JARDIANCE | empagliflozin | TABLET;ORAL | 204629 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0152 | N | 0597-0152-90 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 1, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 18, 2019 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN | ||||||||
| Regulatory Exclusivity Expiration: | Aug 1, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 2, 2019 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE | ||||||||
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