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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203437

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NDA 203437 describes ENTACAPONE, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Sun Pharma Global, and Wockhardt Ltd, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the ENTACAPONE profile page.

The generic ingredient in ENTACAPONE is entacapone. There are nineteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the entacapone profile page.
Summary for 203437
Tradename:ENTACAPONE
Applicant:Aurobindo Pharma Ltd
Ingredient:entacapone
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203437
Suppliers and Packaging for NDA: 203437
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTACAPONE entacapone TABLET;ORAL 203437 ANDA AvPAK 50268-295 N 50268-295-15
ENTACAPONE entacapone TABLET;ORAL 203437 ANDA American Health Packaging 60687-188 N 60687-188-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jun 19, 2015TE:ABRLD:No

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