Details for New Drug Application (NDA): 077793
NDA 077793 describes PRAVASTATIN SODIUM, which is a drug marketed by Accord Hlthcare, Apotex, Aurobindo Pharma, Aurobindo Pharma Usa, Biocon Pharma, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hisun Pharm Hangzhou, Pharmazone, Pharmobedient, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Watson Labs, and Zydus Pharms Usa, and is included in eighteen NDAs. It is available from thirty-five suppliers. Additional details are available on the PRAVASTATIN SODIUM profile page.
The generic ingredient in PRAVASTATIN SODIUM is pravastatin sodium. There is one drug master file entry for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
The generic ingredient in PRAVASTATIN SODIUM is pravastatin sodium. There is one drug master file entry for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 077793
| Tradename: | PRAVASTATIN SODIUM |
| Applicant: | Aurobindo Pharma Usa |
| Ingredient: | pravastatin sodium |
| Patents: | 0 |
Pharmacology for NDA: 077793
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 077793
Suppliers and Packaging for NDA: 077793
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 077793 | ANDA | Teva Pharmaceuticals, Inc. | 0480-7270 | 0480-7270-10 | 1000 TABLET in 1 BOTTLE (0480-7270-10) |
| PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 077793 | ANDA | Teva Pharmaceuticals, Inc. | 0480-7270 | 0480-7270-98 | 90 TABLET in 1 BOTTLE (0480-7270-98) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Jan 15, 2008 | TE: | AB | RLD: | No | ||||
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