Details for New Drug Application (NDA): 078155
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NDA 078155 describes SIMVASTATIN, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Micro Labs, Oxford Pharms, Pharmobedient, Rising, Sun Pharm Inds Ltd, Watson Labs Teva, Yiling, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from twenty-nine suppliers. Additional details are available on the SIMVASTATIN profile page.
The generic ingredient in SIMVASTATIN is simvastatin. There are forty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
The generic ingredient in SIMVASTATIN is simvastatin. There are forty drug master file entries for this compound. Thirty 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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