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Last Updated: November 21, 2024

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 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-five 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-seven 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
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 31722-510-01 100 TABLET, FILM COATED in 1 BOTTLE (31722-510-01)
SIMVASTATIN simvastatin TABLET;ORAL 200895 ANDA Camber Pharmaceuticals, Inc. 31722-510 31722-510-10 1000 TABLET, FILM COATED in 1 BOTTLE (31722-510-10)

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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