Last Updated: September 28, 2026

Details for New Drug Application (NDA): 090548

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NDA 090548 describes ATORVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Graviti Pharms, Hetero Labs Ltd V, Invagen Pharms, Lannett Co Inc, Laurus, Lepu Pharm, Lupin, Macleods Pharms, Mankind Pharma, Micro Labs Ltd India, MSN, Mylan Pharms Inc, Perrigo R And D, Sciegen Pharms, Shandong Xinhua, Strides Pharma, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Inc, Teva Pharms Usa, Umedica, and Zydus Pharms, and is included in thirty-three NDAs. It is available from fifty-eight suppliers. Additional details are available on the ATORVASTATIN CALCIUM profile page.

The generic ingredient in ATORVASTATIN CALCIUM is atorvastatin calcium. There is one drug master file entry for this compound. Sixty suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.

Summary for 090548

Tradename:	ATORVASTATIN CALCIUM
Applicant:	Apotex Inc
Ingredient:	atorvastatin calcium
Patents:	0

Pharmacology for NDA: 090548

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 090548

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Suppliers and Packaging for NDA: 090548

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	090548	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8006	0615-8006-05	15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8006-05)
ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	090548	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8006	0615-8006-07	7 TABLET, FILM COATED in 1 BLISTER PACK (0615-8006-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	May 29, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	May 29, 2012	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE
Approval Date:	May 29, 2012	TE:	AB	RLD:	No

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