Details for New Drug Application (NDA): 207068
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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 207068
Tradename: | PRAVASTATIN SODIUM |
Applicant: | Accord Hlthcare |
Ingredient: | pravastatin sodium |
Patents: | 0 |
Pharmacology for NDA: 207068
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 207068
Suppliers and Packaging for NDA: 207068
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 207068 | ANDA | Accord Healthcare Inc. | 16729-008 | 16729-008-15 | 90 TABLET in 1 BOTTLE (16729-008-15) |
PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 207068 | ANDA | Accord Healthcare Inc. | 16729-008 | 16729-008-16 | 500 TABLET in 1 BOTTLE (16729-008-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 17, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Nov 17, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Nov 17, 2016 | TE: | AB | RLD: | No |
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