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BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Medtronic
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Dow
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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076939

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NDA 076939 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-eight 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-nine suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.

Summary for 076939

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076939

Medical Subject Heading (MeSH) Categories for 076939

Suppliers and Packaging for NDA: 076939

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076939 ANDA Actavis Pharma, Inc. 16252-527 16252-527-50 500 TABLET in 1 BOTTLE (16252-527-50)
PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076939 ANDA Actavis Pharma, Inc. 16252-527 16252-527-90 90 TABLET in 1 BOTTLE (16252-527-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Dec 28, 2007TE:ABRLD:No

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

UBS
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US Army

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