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Details for New Drug Application (NDA): 078155

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NDA 078155 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, Tcg Fluent Pharma, 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-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-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: 078155

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078155

Suppliers and Packaging for NDA: 078155

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 078155 ANDA Blenheim Pharmacal, Inc. 10544-907 10544-907-30 30 TABLET, FILM COATED in 1 BOTTLE (10544-907-30)
TABLET;ORAL 078155 ANDA Blenheim Pharmacal, Inc. 10544-908 10544-908-90 90 TABLET, FILM COATED in 1 BOTTLE (10544-908-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Feb 26, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 26, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Feb 26, 2008TE:ABRLD:No

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