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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 077491

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NDA 077491 describes PRAVASTATIN SODIUM, which is a drug marketed by Accord Hlthcare, Apnar Pharma Lp, Apotex, Aurobindo Pharma, Aurobindo Pharma Usa, Biocon Pharma, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hisun Pharm Hangzhou, Pharmobedient, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Watson Labs, and Zydus Pharms Usa, and is included in eighteen NDAs. It is available from thirty-six suppliers. Additional details are available on the PRAVASTATIN SODIUM profile page.

The generic ingredient in PRAVASTATIN SODIUM is pravastatin sodium. There are sixteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.

Summary for 077491

Tradename:	PRAVASTATIN SODIUM
Applicant:	Apnar Pharma Lp
Ingredient:	pravastatin sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 077491

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Feb 11, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 23, 2006	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Oct 23, 2006	TE:	AB	RLD:	No

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