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Details for New Drug Application (NDA): 019898

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NDA 019898 describes PRAVACHOL, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from one supplier. Additional details are available on the PRAVACHOL profile page.

The generic ingredient in PRAVACHOL 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: 019898

Bristol Myers Squibb
pravastatin sodium
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 019898

Suppliers and Packaging for NDA: 019898

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
pravastatin sodium
TABLET;ORAL 019898 NDA E.R. Squibb & Sons, L.L.C. 0003-5178 0003-5178-05 90 TABLET in 1 BOTTLE (0003-5178-05)
pravastatin sodium
TABLET;ORAL 019898 NDA E.R. Squibb & Sons, L.L.C. 0003-5194 0003-5194-10 90 TABLET in 1 BOTTLE (0003-5194-10)

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 31, 1991TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 31, 1991TE:ABRLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Mar 22, 1993TE:ABRLD:No

Expired Orange Book Patents for NDA: 019898

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
pravastatin sodium
TABLET;ORAL019898-002Oct 31, 19914,346,227*PED► subscribe
Bristol Myers Squibb
pravastatin sodium
TABLET;ORAL019898-004Mar 22, 19935,030,447*PED► subscribe
Bristol Myers Squibb
pravastatin sodium
TABLET;ORAL019898-008Dec 18, 20014,346,227*PED► subscribe
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