Details for New Drug Application (NDA): 077491
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The generic ingredient in PRAVASTATIN SODIUM is pravastatin sodium. There are sixteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 077491
Tradename: | PRAVASTATIN SODIUM |
Applicant: | Apnar Pharma Lp |
Ingredient: | pravastatin sodium |
Patents: | 0 |
Pharmacology for NDA: 077491
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 077491
Suppliers and Packaging for NDA: 077491
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 077491 | ANDA | Apnar Pharma LP | 24689-140 | 24689-140-02 | 90 TABLET in 1 BOTTLE (24689-140-02) |
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 077491 | ANDA | Apnar Pharma LP | 24689-141 | 24689-141-02 | 90 TABLET in 1 BOTTLE (24689-141-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Feb 11, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 23, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Oct 23, 2006 | TE: | AB | RLD: | No |
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