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Details for New Drug Application (NDA): 203437

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NDA 203437 describes ENTACAPONE, which is a drug marketed by Aurobindo Pharma Ltd, Wockhardt Ltd, Sun Pharma Global, and Mylan Pharms Inc, and is included in four NDAs. It is available from five 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. Fourteen suppliers are listed for this compound. Additional details are available on the entacapone profile page.

Summary for NDA: 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 American Health Packaging 60687-188 60687-188-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-188-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-188-11)
ENTACAPONE
entacapone
TABLET;ORAL 203437 ANDA Aurobindo Pharma Limited 65862-654 65862-654-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-654-01)

Summary for product number 001

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


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