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Generated: December 18, 2018

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Details for New Drug Application (NDA): 021687

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NDA 021687 describes VYTORIN, which is a drug marketed by Msd Intl and is included in one NDA. It is available from three suppliers. Additional details are available on the VYTORIN profile page.

The generic ingredient in VYTORIN is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Summary for 021687
Tradename:VYTORIN
Applicant:Msd Intl
Ingredient:ezetimibe; simvastatin
Patents:0
Pharmacology for NDA: 021687
Suppliers and Packaging for NDA: 021687
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687 NDA Rebel Distributors Corp 21695-325 21695-325-30 30 TABLET in 1 BOTTLE (21695-325-30)
VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687 NDA Rebel Distributors Corp 21695-339 21695-339-30 30 TABLET in 1 BOTTLE (21695-339-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;10MG
Approval Date:Jul 23, 2004TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;20MG
Approval Date:Jul 23, 2004TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;40MG
Approval Date:Jul 23, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021687

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-003 Jul 23, 2004 ➤ Sign Up ➤ Sign Up
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-004 Jul 23, 2004 ➤ Sign Up ➤ Sign Up
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-002 Jul 23, 2004 ➤ Sign Up ➤ Sign Up
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-003 Jul 23, 2004 ➤ Sign Up ➤ Sign Up
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-001 Jul 23, 2004 ➤ Sign Up ➤ Sign Up
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-004 Jul 23, 2004 ➤ Sign Up ➤ Sign Up
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-002 Jul 23, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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