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Generated: August 21, 2017

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 Cipla Ltd, Mylan, Dr Reddys Labs Inc, Lupin Pharms, Pliva Hrvatska Doo, Watson Labs, Apotex Inc, Ranbaxy Labs Ltd, Zydus Pharms Usa, Teva, Aurobindo Pharma Ltd, Accord Hlthcare, Glenmark Generics, Mylan Pharms Inc, Sandoz, and Teva Pharms, and is included in seventeen 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 NDA: 076397

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

Pharmacology for NDA: 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 0615-7868-39 30 TABLET in 1 BLISTER PACK (0615-7868-39)
PRAVASTATIN SODIUM
pravastatin sodium
TABLET;ORAL 076397 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7869 0615-7869-39 30 TABLET in 1 BLISTER PACK (0615-7869-39)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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