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Details for New Drug Application (NDA): 206679

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NDA 206679 describes SIMVASTATIN, which is a drug marketed by Lupin, Biocon Limited, Oxford Pharms, Zydus Pharms Usa, Dr Reddys Labs Inc, Ivax Sub Teva Pharms, Accord Hlthcare, Synthon Pharms, Sandoz Inc, Mylan Pharms Inc, Rosemont Pharms Ltd, Micro Labs Ltd, Sun Pharm Inds Ltd, Watson Labs, Aurobindo Pharma, and Hetero Labs Ltd Iii, and is included in sixteen NDAs. It is available from sixty-two suppliers. Additional details are available on the SIMVASTATIN profile page.

The generic ingredient in SIMVASTATIN is simvastatin. There are thirty-nine drug master file entries for this compound. Sixty-four suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the simvastatin profile page.

Summary for NDA: 206679

Tradename:
SIMVASTATIN
Applicant:
Rosemont Pharms Ltd
Ingredient:
simvastatin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength20MG/5ML
Approval Date:Apr 21, 2016TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/5ML
Approval Date:Apr 21, 2016TE:RLD:Yes


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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