Details for New Drug Application (NDA): 076052
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The generic ingredient in SIMVASTATIN is simvastatin. There are forty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 076052
Tradename: | SIMVASTATIN |
Applicant: | Ivax Sub Teva Pharms |
Ingredient: | simvastatin |
Patents: | 0 |
Pharmacology for NDA: 076052
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076052
Suppliers and Packaging for NDA: 076052
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SIMVASTATIN | simvastatin | TABLET;ORAL | 076052 | ANDA | Proficient Rx LP | 71205-070 | 71205-070-30 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-070-30) |
SIMVASTATIN | simvastatin | TABLET;ORAL | 076052 | ANDA | Proficient Rx LP | 71205-070 | 71205-070-60 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-070-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jun 23, 2006 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jun 23, 2006 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jun 23, 2006 | TE: | RLD: | No |
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