Details for New Drug Application (NDA): 207068
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NDA 207068 describes PRAVASTATIN SODIUM, which is a drug marketed by Accord Hlthcare, Apnar Pharma Lp, Apotex, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hisun Pharm Hangzhou, Norvium Bioscience, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Teva, Teva Pharms, Watson Labs, and Zydus Pharms Usa, and is included in eighteen NDAs. It is available from forty-one suppliers. Additional details are available on the PRAVASTATIN SODIUM profile page.
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.
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 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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