Details for New Drug Application (NDA): 076714
✉ 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-one suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 076714
Tradename: | PRAVASTATIN SODIUM |
Applicant: | Dr Reddys Labs Inc |
Ingredient: | pravastatin sodium |
Patents: | 0 |
Pharmacology for NDA: 076714
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076714
Suppliers and Packaging for NDA: 076714
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 076714 | ANDA | Dr.Reddy's Laboratories Limited | 55111-229 | 55111-229-01 | 100 TABLET in 1 BOTTLE (55111-229-01) |
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 076714 | ANDA | Dr.Reddy's Laboratories Limited | 55111-229 | 55111-229-05 | 500 TABLET in 1 BOTTLE (55111-229-05) |
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 |
Complete Access Available with Subscription