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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 091226

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NDA 091226 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 Ltd, Macleods Pharms Ltd, Mankind Pharma, Micro Labs Ltd India, MSN, Mylan Pharms Inc, Perrigo R And D, Sciegen Pharms Inc, 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-seven suppliers. Additional details are available on the ATORVASTATIN CALCIUM profile page.

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

Summary for 091226

Tradename:	ATORVASTATIN CALCIUM
Applicant:	Mylan Pharms Inc
Ingredient:	atorvastatin calcium
Patents:	0

Pharmacology for NDA: 091226

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 091226

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Suppliers and Packaging for NDA: 091226

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	091226	ANDA	Mylan Pharmaceuticals Inc.	0378-3950	0378-3950-05	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3950-05)
ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	091226	ANDA	Mylan Pharmaceuticals Inc.	0378-3950	0378-3950-77	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3950-77)

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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