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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 019766


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NDA 019766 describes ZOCOR, which is a drug marketed by Organon 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. Thirty-six suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 019766
Tradename:ZOCOR
Applicant:Organon
Ingredient:simvastatin
Patents:0
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 Organon LLC 78206-180 78206-180-01 30 TABLET, FILM COATED in 1 BOTTLE (78206-180-01)
ZOCOR simvastatin TABLET;ORAL 019766 NDA Organon LLC 78206-180 78206-180-02 90 TABLET, FILM COATED in 1 BOTTLE (78206-180-02)

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
Organon ZOCOR simvastatin TABLET;ORAL 019766-002 Dec 23, 1991 ⤷  Sign Up ⤷  Sign Up
Organon ZOCOR simvastatin TABLET;ORAL 019766-004 Dec 23, 1991 ⤷  Sign Up ⤷  Sign Up
Organon ZOCOR simvastatin TABLET;ORAL 019766-001 Dec 23, 1991 ⤷  Sign Up ⤷  Sign Up
Organon ZOCOR simvastatin TABLET;ORAL 019766-005 Jul 10, 1998 ⤷  Sign Up ⤷  Sign Up
Organon ZOCOR simvastatin TABLET;ORAL 019766-004 Dec 23, 1991 ⤷  Sign Up ⤷  Sign Up
Organon ZOCOR simvastatin TABLET;ORAL 019766-005 Jul 10, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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