Details for New Drug Application (NDA): 078296
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The generic ingredient in LOVASTATIN is lovastatin. There are thirty-three drug master file entries for this compound. Twenty-three 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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