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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 204991

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NDA 204991 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 204991

Tradename:	ATORVASTATIN CALCIUM
Applicant:	Lupin Ltd
Ingredient:	atorvastatin calcium
Patents:	0

Pharmacology for NDA: 204991

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 204991

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Suppliers and Packaging for NDA: 204991

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	204991	ANDA	A-S Medication Solutions	50090-5632	50090-5632-0	30 TABLET in 1 BOTTLE (50090-5632-0)
ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	204991	ANDA	A-S Medication Solutions	50090-5632	50090-5632-1	90 TABLET in 1 BOTTLE (50090-5632-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Mar 6, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Mar 6, 2019	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE
Approval Date:	Mar 6, 2019	TE:		RLD:	No

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