Details for New Drug Application (NDA): 090595
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NDA 090595 describes FLUVASTATIN SODIUM, which is a drug marketed by Mylan Pharms Inc, Teva Pharms, Beijing, Norvium Bioscience, and Teva Pharms Usa, and is included in five NDAs. It is available from four suppliers. Additional details are available on the FLUVASTATIN SODIUM profile page.
The generic ingredient in FLUVASTATIN SODIUM is fluvastatin sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.
The generic ingredient in FLUVASTATIN SODIUM is fluvastatin sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.
Summary for 090595
| Tradename: | FLUVASTATIN SODIUM |
| Applicant: | Mylan Pharms Inc |
| Ingredient: | fluvastatin sodium |
| Patents: | 0 |
Pharmacology for NDA: 090595
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Suppliers and Packaging for NDA: 090595
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUVASTATIN SODIUM | fluvastatin sodium | CAPSULE;ORAL | 090595 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8020 | 0378-8020-77 | 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8020-77) |
| FLUVASTATIN SODIUM | fluvastatin sodium | CAPSULE;ORAL | 090595 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8020 | 0378-8020-93 | 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-8020-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Apr 11, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Apr 11, 2012 | TE: | AB | RLD: | No | ||||
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