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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 208478

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NDA 208478 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, 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 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 208478

Tradename:	ATORVASTATIN CALCIUM
Applicant:	Perrigo R And D
Ingredient:	atorvastatin calcium
Patents:	0

Medical Subject Heading (MeSH) Categories for 208478

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jun 23, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jun 23, 2020	TE:		RLD:	No

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