Details for New Drug Application (NDA): 206111
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NDA 206111 describes SYNJARDY, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. There are ten patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SYNJARDY profile page.
The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.
The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.
Summary for 206111
| Tradename: | SYNJARDY |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | empagliflozin; metformin hydrochloride |
| Patents: | 8 |
Pharmacology for NDA: 206111
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 206111
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYNJARDY | empagliflozin; metformin hydrochloride | TABLET;ORAL | 206111 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0159 | 0597-0159-18 | 180 TABLET in 1 BOTTLE (0597-0159-18) |
| SYNJARDY | empagliflozin; metformin hydrochloride | TABLET;ORAL | 206111 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0159 | 0597-0159-60 | 60 TABLET in 1 BOTTLE (0597-0159-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;500MG | ||||
| Approval Date: | Aug 26, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Dec 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | 10,258,637*PED | Patent Expiration: | Oct 3, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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