Details for New Drug Application (NDA): 077987
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NDA 077987 describes PRAVASTATIN SODIUM, which is a drug marketed by Accord Hlthcare, Apnar Pharma Lp, Apotex, Aurobindo Pharma, Aurobindo Pharma Usa, Biocon Pharma, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hisun Pharm Hangzhou, Pharmobedient, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Watson Labs, and Zydus Pharms Usa, and is included in eighteen NDAs. It is available from thirty-seven 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. Thirty-seven 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 077987
| Tradename: | PRAVASTATIN SODIUM |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | pravastatin sodium |
| Patents: | 0 |
Pharmacology for NDA: 077987
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 077987
Suppliers and Packaging for NDA: 077987
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 077987 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8539 | 0615-8539-39 | 30 TABLET in 1 BLISTER PACK (0615-8539-39) |
| PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 077987 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8540 | 0615-8540-05 | 15 TABLET in 1 BLISTER PACK (0615-8540-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 11, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | May 11, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | May 11, 2007 | TE: | AB | RLD: | No | ||||
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