Details for New Drug Application (NDA): 206111
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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: | ⤷ Sign Up | Patent Expiration: | Oct 3, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y |
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