Details for New Drug Application (NDA): 078155
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The generic ingredient in SIMVASTATIN is simvastatin. There are forty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 078155
Tradename: | SIMVASTATIN |
Applicant: | Accord Hlthcare |
Ingredient: | simvastatin |
Patents: | 0 |
Pharmacology for NDA: 078155
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 078155
Suppliers and Packaging for NDA: 078155
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SIMVASTATIN | simvastatin | TABLET;ORAL | 078155 | ANDA | Accord Healthcare, Inc. | 16729-004 | 16729-004-10 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-004-10) |
SIMVASTATIN | simvastatin | TABLET;ORAL | 078155 | ANDA | Accord Healthcare, Inc. | 16729-004 | 16729-004-15 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-004-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Feb 26, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Feb 26, 2008 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Feb 26, 2008 | TE: | AB | RLD: | No |
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