Details for New Drug Application (NDA): 075551
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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 075551
Tradename: | LOVASTATIN |
Applicant: | Teva |
Ingredient: | lovastatin |
Patents: | 0 |
Pharmacology for NDA: 075551
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 075551
Suppliers and Packaging for NDA: 075551
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOVASTATIN | lovastatin | TABLET;ORAL | 075551 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0576 | 0093-0576-06 | 60 TABLET in 1 BOTTLE (0093-0576-06) |
LOVASTATIN | lovastatin | TABLET;ORAL | 075551 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0576 | 0093-0576-10 | 1000 TABLET in 1 BOTTLE (0093-0576-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
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 | 10MG | ||||
Approval Date: | Dec 17, 2001 | TE: | AB | RLD: | No |
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