Details for New Drug Application (NDA): 078296
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NDA 078296 describes LOVASTATIN, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Corepharma, Epic Pharma Llc, Lupin, Sun Pharm Industries, and Teva, and is included in ten NDAs. It is available from nineteen suppliers. Additional details are available on the LOVASTATIN profile page.
The generic ingredient in LOVASTATIN is lovastatin. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the lovastatin profile page.
The generic ingredient in LOVASTATIN is lovastatin. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the lovastatin profile page.
Summary for 078296
| Tradename: | LOVASTATIN |
| Applicant: | Lupin |
| Ingredient: | lovastatin |
| Patents: | 0 |
Pharmacology for NDA: 078296
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 078296
Suppliers and Packaging for NDA: 078296
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOVASTATIN | lovastatin | TABLET;ORAL | 078296 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8151 | 0615-8151-39 | 30 TABLET in 1 BLISTER PACK (0615-8151-39) |
| LOVASTATIN | lovastatin | TABLET;ORAL | 078296 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8152 | 0615-8152-39 | 30 TABLET in 1 BLISTER PACK (0615-8152-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 14, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Nov 1, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Nov 1, 2007 | TE: | AB | RLD: | No | ||||
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