Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
Product Details for NDA 202343
JUVISYNC (SIMVASTATIN; SITAGLIPTIN PHOSPHATE)
10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 004
Approval Date: Sep 18, 2012
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
JUVISYNC (SIMVASTATIN; SITAGLIPTIN PHOSPHATE)
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 004
Approval Date: Sep 18, 2012
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 001
Approval Date: Oct 7, 2011
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
JUVISYNC (SIMVASTATIN; SITAGLIPTIN PHOSPHATE)
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 001
Approval Date: Oct 7, 2011
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 005
Approval Date: Sep 18, 2012
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
JUVISYNC (SIMVASTATIN; SITAGLIPTIN PHOSPHATE)
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 005
Approval Date: Sep 18, 2012
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 002
Approval Date: Oct 7, 2011
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
JUVISYNC (SIMVASTATIN; SITAGLIPTIN PHOSPHATE)
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 002
Approval Date: Oct 7, 2011
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 006
Approval Date: Sep 18, 2012
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
JUVISYNC (SIMVASTATIN; SITAGLIPTIN PHOSPHATE)
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 006
Approval Date: Sep 18, 2012
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 003
Approval Date: Oct 7, 2011
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: JUVISYNC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202343
Product Number: 003
Approval Date: Oct 7, 2011
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
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