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Details for New Drug Application (NDA): 077917

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NDA 077917 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-three 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-four 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: 077917

Tradename:
PRAVASTATIN SODIUM
Applicant:
Lupin Pharms
Ingredient:
pravastatin sodium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077917

Suppliers and Packaging for NDA: 077917

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAVASTATIN SODIUM
pravastatin sodium
TABLET;ORAL 077917 ANDA Lupin Pharmaceuticals, Inc. 68180-485 68180-485-02 500 TABLET in 1 BOTTLE (68180-485-02)
PRAVASTATIN SODIUM
pravastatin sodium
TABLET;ORAL 077917 ANDA Lupin Pharmaceuticals, Inc. 68180-485 68180-485-03 1000 TABLET in 1 BOTTLE (68180-485-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 8, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jan 8, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jan 8, 2008TE:ABRLD:No


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