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Last Updated: April 16, 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-seven 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019766

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 019766

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents

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:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Dec 23, 1991	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 23, 1991	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Dec 23, 1991	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019766

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-001	Dec 23, 1991	⤷ Try a Trial	⤷ Try a Trial
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-002	Dec 23, 1991	⤷ Try a Trial	⤷ Try a Trial
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-002	Dec 23, 1991	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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