Details for New Drug Application (NDA): 208658
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The generic ingredient in SYNJARDY XR 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 208658
Tradename: | SYNJARDY XR |
Applicant: | Boehringer Ingelheim |
Ingredient: | empagliflozin; metformin hydrochloride |
Patents: | 9 |
Pharmacology for NDA: 208658
Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 208658
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0280 | 0597-0280-36 | 1 BOTTLE in 1 CARTON (0597-0280-36) / 7 TABLET, EXTENDED RELEASE in 1 BOTTLE |
SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0280 | 0597-0280-73 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0280-73) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;1GM | ||||
Approval Date: | Dec 9, 2016 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Dec 20, 2026 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Regulatory Exclusivity Expiration: | Jun 20, 2026 | ||||||||
Regulatory Exclusivity Use: | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091 | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 3, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 208658
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-002 | Dec 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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