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 four suppliers. There are ten 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. Four 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. Four 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: | 10 |
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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | LABELING REVISIONS RELATED TO CLINICAL STUDIES | ||||||||
| Regulatory Exclusivity Expiration: | Jun 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Aug 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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