Details for New Drug Application (NDA): 206557
✉ Email this page to a colleague
NDA 206557 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 206557
| Tradename: | SIMVASTATIN |
| Applicant: | Invagen Pharms |
| Ingredient: | simvastatin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 206557
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 13, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Nov 13, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Nov 13, 2017 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
