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Serving leading biopharmaceutical companies globally:

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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200895

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NDA 200895 describes SIMVASTATIN, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Limited, Dr Reddys Labs Inc, Hetero Labs Ltd Iii, Hisun Pharm Hangzhou, Ivax Sub Teva Pharms, Lupin, Mylan Pharms Inc, Oxford Pharms, Sandoz Inc, Sun Pharm Inds Ltd, Viva Hlthcare, Watson Labs Teva, and Zydus Pharms Usa, and is included in sixteen NDAs. It is available from sixty-three 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-five suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 200895
Tradename:SIMVASTATIN
Applicant:Hetero Labs Ltd Iii
Ingredient:simvastatin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200895
Suppliers and Packaging for NDA: 200895
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN simvastatin TABLET;ORAL 200895 ANDA Camber Pharmaceuticals, Inc. 31722-510 31722-510-10 1000 TABLET, FILM COATED in 1 BOTTLE (31722-510-10)
SIMVASTATIN simvastatin TABLET;ORAL 200895 ANDA Camber Pharmaceuticals, Inc. 31722-510 31722-510-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-510-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 25, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 25, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 25, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Fuji
Harvard Business School
Farmers Insurance
Daiichi Sankyo
Mallinckrodt
Moodys
Chinese Patent Office
Julphar
Express Scripts

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