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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 076714


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NDA 076714 describes PRAVASTATIN SODIUM, which is a drug marketed by Accord Hlthcare, Apnar Pharma Lp, Apotex, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hisun Pharm Hangzhou, Norvium Bioscience, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Teva, Teva Pharms, Watson Labs, and Zydus Pharms Usa, and is included in eighteen NDAs. It is available from forty-one 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. Forty-one suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 076714
Tradename:PRAVASTATIN SODIUM
Applicant:Dr Reddys Labs Inc
Ingredient:pravastatin sodium
Patents:0
Pharmacology for NDA: 076714
Medical Subject Heading (MeSH) Categories for 076714
Suppliers and Packaging for NDA: 076714
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076714 ANDA Dr.Reddy's Laboratories Limited 55111-229 55111-229-01 100 TABLET in 1 BOTTLE (55111-229-01)
PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076714 ANDA Dr.Reddy's Laboratories Limited 55111-229 55111-229-05 500 TABLET in 1 BOTTLE (55111-229-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 23, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 23, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Oct 23, 2006TE:ABRLD:No

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