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Generated: November 18, 2018

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Details for New Drug Application (NDA): 209803

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NDA 209803 describes STEGLATRO, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the STEGLATRO profile page.

The generic ingredient in STEGLATRO is ertugliflozin. One supplier is listed for this compound. Additional details are available on the ertugliflozin profile page.
Summary for 209803
Tradename:STEGLATRO
Applicant:Merck Sharp Dohme
Ingredient:ertugliflozin
Patents:1
Generic Entry Opportunity Date for 209803
Generic Entry Date for 209803*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 Corp. 0006-5363 0006-5363-03 30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-03)
STEGLATRO ertugliflozin TABLET;ORAL 209803 NDA Merck Sharp & Dohme Corp. 0006-5363 0006-5363-06 90 TABLET, FILM COATED in 1 BOTTLE (0006-5363-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 19, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Jul 13, 2030Product Flag?YSubstance Flag?YDelist 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:RXDosage:TABLET;ORALStrength15MG
Approval Date:Dec 19, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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