Details for New Drug Application (NDA): 076341
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The generic ingredient in PRAVASTATIN SODIUM is pravastatin sodium. There are sixteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 076341
Tradename: | PRAVASTATIN SODIUM |
Applicant: | Apotex |
Ingredient: | pravastatin sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076341
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076341
Suppliers and Packaging for NDA: 076341
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 076341 | ANDA | Major Pharmaceuticals | 0904-5891 | 0904-5891-61 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5891-61) / 1 TABLET in 1 BLISTER PACK |
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 076341 | ANDA | Major Pharmaceuticals | 0904-5892 | 0904-5892-61 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5892-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 23, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Oct 23, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Oct 23, 2006 | TE: | AB | RLD: | No |
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