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Pravastatin sodium - Generic Drug Details

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Pravastatin sodium is the generic ingredient in two branded drugs 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, Teva Pharms, and Bristol Myers Squibb, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for pravastatin sodium. Forty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: pravastatin sodium

Tradenames:2
Patents:0
Applicants:15
NDAs:16
Drug Master File Entries: see list16
Suppliers / Packaging: see list44
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: pravastatin sodium

Tentative approvals for PRAVASTATIN SODIUM

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL80MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
PRAVACHOL
pravastatin sodium
TABLET;ORAL019898-008Dec 18, 2001RXYes► subscribe► subscribe
Sandoz
PRAVASTATIN SODIUM
pravastatin sodium
TABLET;ORAL077491-001Feb 11, 2008RXNo► subscribe► subscribe
Ranbaxy Labs Ltd
PRAVASTATIN SODIUM
pravastatin sodium
TABLET;ORAL076445-004Apr 23, 2007DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: pravastatin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
PRAVACHOL
pravastatin sodium
TABLET;ORAL019898-004Mar 22, 19935,180,589*PED► subscribe
Bristol Myers Squibb
PRAVACHOL
pravastatin sodium
TABLET;ORAL019898-008Dec 18, 20015,180,589*PED► subscribe
Bristol Myers Squibb
PRAVACHOL
pravastatin sodium
TABLET;ORAL019898-002Oct 31, 19914,346,227*PED► subscribe
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