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Generated: November 14, 2018

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Details for New Drug Application (NDA): 019766

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NDA 019766 describes ZOCOR, which is a drug marketed by Msd Merck Co and is included in one NDA. It is available from one supplier. Additional details are available on the ZOCOR profile page.

The generic ingredient in ZOCOR is simvastatin. There are forty drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 019766
Tradename:ZOCOR
Applicant:Msd Merck Co
Ingredient:simvastatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019766
Suppliers and Packaging for NDA: 019766
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOCOR simvastatin TABLET;ORAL 019766 NDA Merck Sharp & Dohme Corp. 0006-0543 0006-0543-31 30 TABLET, FILM COATED in 1 BOTTLE (0006-0543-31)
ZOCOR simvastatin TABLET;ORAL 019766 NDA Merck Sharp & Dohme Corp. 0006-0543 0006-0543-54 90 TABLET, FILM COATED in 1 BOTTLE (0006-0543-54)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 23, 1991TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 23, 1991TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 23, 1991TE:ABRLD:Yes

Expired US Patents for NDA 019766

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Merck Co ZOCOR simvastatin TABLET;ORAL 019766-003 Dec 23, 1991 ➤ Sign Up ➤ Sign Up
Msd Merck Co ZOCOR simvastatin TABLET;ORAL 019766-001 Dec 23, 1991 ➤ Sign Up ➤ Sign Up
Msd Merck Co ZOCOR simvastatin TABLET;ORAL 019766-002 Dec 23, 1991 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
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Chubb
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