Details for New Drug Application (NDA): 209803
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NDA 209803 describes STEGLATRO, which is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the STEGLATRO profile page.
The generic ingredient in STEGLATRO is ertugliflozin. Two suppliers are listed for this compound. Additional details are available on the ertugliflozin profile page.
The generic ingredient in STEGLATRO is ertugliflozin. Two suppliers are listed for this compound. Additional details are available on the ertugliflozin profile page.
Summary for 209803
| Tradename: | STEGLATRO |
| Applicant: | Msd Sub Merck |
| Ingredient: | ertugliflozin |
| Patents: | 1 |
Suppliers and Packaging for NDA: 209803
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STEGLATRO | ertugliflozin | TABLET;ORAL | 209803 | NDA | Merck Sharp & Dohme LLC | 0006-5363 | 0006-5363-03 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-03) |
| STEGLATRO | ertugliflozin | TABLET;ORAL | 209803 | NDA | Merck Sharp & Dohme LLC | 0006-5363 | 0006-5363-06 | 90 TABLET, FILM COATED in 1 BOTTLE (0006-5363-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Dec 19, 2017 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Sep 17, 2024 | ||||||||
| Regulatory Exclusivity Use: | REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 13, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Dec 19, 2017 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Sep 17, 2024 | ||||||||
| Regulatory Exclusivity Use: | REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV | ||||||||
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