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Last Updated: December 15, 2019

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Details for New Drug Application (NDA): 076397

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NDA 076397 describes PRAVASTATIN SODIUM, which is a drug marketed by Accord Hlthcare, Apnar Pharma Lp, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Generics, Hisun Pharm Hangzhou, Lupin Pharms, Mylan, Mylan Pharms Inc, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Teva, Teva Pharms, Watson Labs, and Zydus Pharms Usa, and is included in nineteen NDAs. It is available from forty 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 076397
Applicant:Apnar Pharma Lp
Ingredient:pravastatin sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 076397
Medical Subject Heading (MeSH) Categories for 076397
Suppliers and Packaging for NDA: 076397
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076397 ANDA Sandoz Inc 0781-5231 0781-5231-01 100 TABLET in 1 BOTTLE (0781-5231-01)
PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076397 ANDA Sandoz Inc 0781-5231 0781-5231-10 1000 TABLET in 1 BOTTLE (0781-5231-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
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;ORALStrength10MG
Approval Date:Oct 23, 2006TE:ABRLD:No

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