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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076397

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NDA 076397 describes PRAVASTATIN SODIUM, which is a drug marketed by Accord Hlthcare, Apotex Inc, Appco Pharma Llc, 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 eighteen NDAs. It is available from forty-seven 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-eight suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 076397
Tradename:PRAVASTATIN SODIUM
Applicant:Sandoz
Ingredient:pravastatin sodium
Patents:0
Therapeutic Class:Cardiovascular Agents
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 NCS HealthCare of KY, Inc dba Vangard Labs 0615-7868 N 0615-7868-39
PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076397 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7869 N 0615-7869-39

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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