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Details for New Drug Application (NDA): 077491

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NDA 077491 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-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. There is one tentative approval for this compound. Additional details are available on the pravastatin sodium profile page.

Summary for NDA: 077491

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077491

Suppliers and Packaging for NDA: 077491

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
pravastatin sodium
TABLET;ORAL 077491 ANDA Sandoz Inc 0781-5235 0781-5235-01 100 TABLET in 1 BOTTLE (0781-5235-01)
pravastatin sodium
TABLET;ORAL 077491 ANDA Sandoz Inc 0781-5235 0781-5235-10 1000 TABLET in 1 BOTTLE (0781-5235-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Feb 11, 2008TE:ABRLD:No

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