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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 206669


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NDA 206669 describes ENTACAPONE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Norvium Bioscience, Sun Pharm, Sunshine, and Wockhardt Bio Ag, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the ENTACAPONE profile page.

The generic ingredient in ENTACAPONE is entacapone. There are twenty 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 206669
Tradename:ENTACAPONE
Applicant:Sunshine
Ingredient:entacapone
Patents:0
Pharmacology for NDA: 206669
Suppliers and Packaging for NDA: 206669
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTACAPONE entacapone TABLET;ORAL 206669 ANDA Lannett Company, Inc. 0527-1830 0527-1830-37 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1830-37)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Oct 3, 2018TE:ABRLD:No

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