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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 020702

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NDA 020702 describes LIPITOR, which is a drug marketed by Upjohn and is included in one NDA. It is available from two suppliers. Additional details are available on the LIPITOR profile page.

The generic ingredient in LIPITOR is atorvastatin calcium. There are sixty-two drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.

Summary for 020702

Tradename:	LIPITOR
Applicant:	Upjohn
Ingredient:	atorvastatin calcium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020702

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 020702

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Suppliers and Packaging for NDA: 020702

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIPITOR	atorvastatin calcium	TABLET;ORAL	020702	NDA	Parke-Davis Div of Pfizer Inc	0071-0155	0071-0155-23	90 TABLET, FILM COATED in 1 BOTTLE (0071-0155-23)
LIPITOR	atorvastatin calcium	TABLET;ORAL	020702	NDA	Parke-Davis Div of Pfizer Inc	0071-0156	0071-0156-23	90 TABLET, FILM COATED in 1 BOTTLE (0071-0156-23)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Dec 17, 1996	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Dec 17, 1996	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE
Approval Date:	Dec 17, 1996	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020702

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996	⤷ Try a Trial	⤷ Try a Trial
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996	⤷ Try a Trial	⤷ Try a Trial
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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