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Details for New Drug Application (NDA): 021995

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NDA 021995 describes JANUVIA, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from six suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JANUVIA profile page.

The generic ingredient in JANUVIA is sitagliptin phosphate. There are twenty-four drug master file entries for this compound. Six suppliers are listed for this compound. There are twenty-three tentative approvals for this compound. Additional details are available on the sitagliptin phosphate profile page.

Summary for NDA: 021995

Tradename:
JANUVIA
Applicant:
Merck Sharp Dohme
Ingredient:
sitagliptin phosphate
Patents:3
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 021995

Suppliers and Packaging for NDA: 021995

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JANUVIA
sitagliptin phosphate
TABLET;ORAL 021995 NDA Merck Sharp & Dohme Corp. 0006-0112 0006-0112-28 100 BLISTER PACK in 1 CARTON (0006-0112-28) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0112-01)
JANUVIA
sitagliptin phosphate
TABLET;ORAL 021995 NDA Merck Sharp & Dohme Corp. 0006-0112 0006-0112-31 30 TABLET, FILM COATED in 1 BOTTLE (0006-0112-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Oct 16, 2006TE:RLD:No
Patent:7,125,873Patent Expiration:Jul 26, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
Patent:7,125,873Patent Expiration:Jul 26, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
Patent:7,326,708Patent Expiration:Nov 24, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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