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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 five suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Five suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the ezetimibe; simvastatin profile page.

Summary for NDA: 021687

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;10MG
Approval Date:Jul 23, 2004TE:RLD:Yes
Patent:RE37721*PEDPatent Expiration:Apr 25, 2017Product Flag?Substance Flag?Delist Request?
Patent:RE42461*PEDPatent Expiration:Apr 25, 2017Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;20MG
Approval Date:Jul 23, 2004TE:RLD:Yes
Patent:RE37721*PEDPatent Expiration:Apr 25, 2017Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021687

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-001Jul 23, 20044,444,784► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-003Jul 23, 20045,846,966*PED► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-004Jul 23, 20044,444,784► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-002Jul 23, 20045,846,966*PED► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-003Jul 23, 20044,444,784► Subscribe
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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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