Details for New Drug Application (NDA): 077793
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The generic ingredient in PRAVASTATIN SODIUM is pravastatin sodium. There are sixteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 077793
Tradename: | PRAVASTATIN SODIUM |
Applicant: | Teva Pharms |
Ingredient: | pravastatin sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077793
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 077793
Suppliers and Packaging for NDA: 077793
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | 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 | pravastatin sodium | TABLET;ORAL | 077793 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7270 | 0093-7270-98 | 90 TABLET in 1 BOTTLE (0093-7270-98) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Jan 15, 2008 | TE: | AB | RLD: | No |
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