Details for New Drug Application (NDA): 078103
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NDA 078103 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 078103
| Tradename: | SIMVASTATIN |
| Applicant: | Lupin |
| Ingredient: | simvastatin |
| Patents: | 0 |
Pharmacology for NDA: 078103
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 078103
Suppliers and Packaging for NDA: 078103
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SIMVASTATIN | simvastatin | TABLET;ORAL | 078103 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7992 | 0615-7992-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-05) |
| SIMVASTATIN | simvastatin | TABLET;ORAL | 078103 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7992 | 0615-7992-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 11, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | May 11, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | May 11, 2007 | TE: | AB | RLD: | No | ||||
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