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Details for New Drug Application (NDA): 077793

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NDA 077793 describes PRAVASTATIN SODIUM, which is a drug marketed by Cipla Ltd, Mylan, Dr Reddys Labs Inc, Lupin Pharms, Pliva Hrvatska Doo, Watson Labs, Apotex, Ranbaxy Labs Ltd, Zydus Pharms Usa, Teva, Glenmark Generics, Mylan Pharms Inc, Sandoz, and Teva Pharms, and is included in fifteen NDAs. It is available from forty-two 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-three 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: 077793

Teva Pharms
pravastatin sodium
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 077793

Suppliers and Packaging for NDA: 077793

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
pravastatin sodium
TABLET;ORAL 077793 ANDA Teva Pharmaceuticals USA Inc 0093-7270 0093-7270-10 1000 TABLET in 1 BOTTLE (0093-7270-10)
pravastatin sodium
TABLET;ORAL 077793 ANDA Teva Pharmaceuticals USA Inc 0093-7270 0093-7270-98 90 TABLET in 1 BOTTLE (0093-7270-98)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jan 15, 2008TE:ABRLD:No

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