Details for New Drug Application (NDA): 076056
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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 076056
Tradename: | PRAVASTATIN SODIUM |
Applicant: | Teva |
Ingredient: | pravastatin sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076056
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076056
Suppliers and Packaging for NDA: 076056
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 076056 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0771 | 0093-0771-10 | 1000 TABLET in 1 BOTTLE (0093-0771-10) |
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 076056 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0771 | 0093-0771-98 | 90 TABLET in 1 BOTTLE (0093-0771-98) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 24, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Apr 24, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Apr 24, 2006 | TE: | AB | RLD: | No |
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