Details for New Drug Application (NDA): 209869
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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 209869
Tradename: | PRAVASTATIN SODIUM |
Applicant: | Biocon Pharma |
Ingredient: | pravastatin sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209869
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 209869
Suppliers and Packaging for NDA: 209869
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 209869 | ANDA | Bryant Ranch Prepack | 63629-8904 | 63629-8904-1 | 90 TABLET in 1 BOTTLE (63629-8904-1) |
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 209869 | ANDA | Bryant Ranch Prepack | 63629-8905 | 63629-8905-1 | 1000 TABLET in 1 BOTTLE (63629-8905-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 13, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Apr 13, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Apr 13, 2018 | TE: | AB | RLD: | No |
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