Details for New Drug Application (NDA): 075828
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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 075828
Tradename: | LOVASTATIN |
Applicant: | Actavis Elizabeth |
Ingredient: | lovastatin |
Patents: | 0 |
Pharmacology for NDA: 075828
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 075828
Suppliers and Packaging for NDA: 075828
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOVASTATIN | lovastatin | TABLET;ORAL | 075828 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-995 | 43353-995-45 | 45 TABLET in 1 BOTTLE (43353-995-45) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 17, 2001 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Dec 17, 2001 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Dec 17, 2001 | TE: | AB | RLD: | No |
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