Details for New Drug Application (NDA): 077751
✉ Email this page to a colleague
The generic ingredient in PRAVASTATIN SODIUM is pravastatin sodium. There are sixteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 077751
Tradename: | PRAVASTATIN SODIUM |
Applicant: | Zydus Pharms Usa |
Ingredient: | pravastatin sodium |
Patents: | 0 |
Pharmacology for NDA: 077751
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 077751
Suppliers and Packaging for NDA: 077751
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 077751 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-443 | 43063-443-30 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-443-30) |
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 077751 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-443 | 43063-443-90 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-443-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 30, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Apr 30, 2008 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Apr 30, 2008 | TE: | AB | RLD: | No |
Complete Access Available with Subscription