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Serving leading biopharmaceutical companies globally:

Queensland Health
Citi
Daiichi Sankyo
Cipla
Medtronic
Farmers Insurance
Moodys
AstraZeneca
Colorcon
Express Scripts

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076341

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NDA 076341 describes PRAVASTATIN SODIUM, which is a drug marketed by Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Cipla Ltd, Dr Reddys Labs Inc, Glenmark Generics, Lupin Pharms, Mylan, Mylan Pharms Inc, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Sandoz, Teva, Teva Pharms, Watson Labs, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from forty-nine 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. Fifty suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 076341
Tradename:PRAVASTATIN SODIUM
Applicant:Apotex Inc
Ingredient:pravastatin sodium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076341
Medical Subject Heading (MeSH) Categories for 076341
Suppliers and Packaging for NDA: 076341
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076341 ANDA Major Pharmaceuticals 0904-5891 0904-5891-61 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5891-61) > 1 TABLET in 1 BLISTER PACK
PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076341 ANDA Major Pharmaceuticals 0904-5892 0904-5892-61 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5892-61) > 1 TABLET in 1 BLISTER PACK

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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Serving leading biopharmaceutical companies globally:

Fuji
Federal Trade Commission
Johnson and Johnson
Citi
Argus Health
Farmers Insurance
Daiichi Sankyo
McKinsey
Accenture

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