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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 211886

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NDA 211886 describes ATORVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Agnitio, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, 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, Sandoz Inc, Sciegen Pharms Inc, Shandong Xinhua, Strides Pharma, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Usa, Umedica, and Zydus Pharms, and is included in thirty-two NDAs. It is available from sixty-three 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-six suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.

Summary for 211886

Tradename:	ATORVASTATIN CALCIUM
Applicant:	Shandong Xinhua
Ingredient:	atorvastatin calcium
Patents:	0

Medical Subject Heading (MeSH) Categories for 211886

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jan 25, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jan 25, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE
Approval Date:	Jan 25, 2024	TE:	AB	RLD:	No

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