Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209288

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NDA 209288 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 209288

Tradename:	ATORVASTATIN CALCIUM
Applicant:	Alkem Labs Ltd
Ingredient:	atorvastatin calcium
Patents:	0

Pharmacology for NDA: 209288

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 209288

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Suppliers and Packaging for NDA: 209288

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	209288	ANDA	QPharma, Inc.	42708-141	42708-141-30	30 TABLET, FILM COATED in 1 BOTTLE (42708-141-30)
ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	209288	ANDA	QPharma, Inc.	42708-144	42708-144-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-144-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Dec 21, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Dec 21, 2018	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE
Approval Date:	Dec 21, 2018	TE:	AB	RLD:	No

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