Details for New Drug Application (NDA): 078034
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NDA 078034 describes SIMVASTATIN, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Dr Reddys Labs Inc, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Micro Labs, Norvium Bioscience, Oxford Pharms, Sun Pharm Inds Ltd, Watson Labs Teva, and Zydus Pharms Usa, and is included in sixteen NDAs. It is available from thirty-four 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-six 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-six suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 078034
| Tradename: | SIMVASTATIN |
| Applicant: | Biocon Pharma |
| Ingredient: | simvastatin |
| Patents: | 0 |
Pharmacology for NDA: 078034
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 078034
Suppliers and Packaging for NDA: 078034
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SIMVASTATIN | simvastatin | TABLET;ORAL | 078034 | ANDA | PuraCap Laboratories, LLC | 24658-500 | 24658-500-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (24658-500-10) |
| SIMVASTATIN | simvastatin | TABLET;ORAL | 078034 | ANDA | PuraCap Laboratories, LLC | 24658-500 | 24658-500-30 | 30 TABLET, FILM COATED in 1 BOTTLE (24658-500-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Dec 20, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Dec 20, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 20, 2006 | TE: | AB | RLD: | No | ||||
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