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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "019898."



Active Ingredient: PRAVASTATIN SODIUM
Dosage Form;Route: TABLET;ORAL
Proprietary Name: PRAVACHOL
Applicant: BRISTOL MYERS SQUIBB
Strength: 10MG
Application Number: N019898
Product Number: 002
Approval Date: Oct 31, 1991
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: PRAVASTATIN SODIUM
Dosage Form;Route: TABLET;ORAL
Proprietary Name: PRAVACHOL
Applicant: BRISTOL MYERS SQUIBB
Strength: 20MG
Application Number: N019898
Product Number: 003
Approval Date: Oct 31, 1991
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: PRAVASTATIN SODIUM
Dosage Form;Route: TABLET;ORAL
Proprietary Name: PRAVACHOL
Applicant: BRISTOL MYERS SQUIBB
Strength: 40MG
Application Number: N019898
Product Number: 004
Approval Date: Mar 22, 1993
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: PRAVASTATIN SODIUM
Dosage Form;Route: TABLET;ORAL
Proprietary Name: PRAVACHOL
Applicant: BRISTOL MYERS SQUIBB
Strength: 80MG
Application Number: N019898
Product Number: 008
Approval Date: Dec 18, 2001
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through August 2014
Patent and Generic Drug Product Data Last Updated September 17, 2014

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