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Generated: November 14, 2018

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Details for New Drug Application (NDA): 209449

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NDA 209449 describes NITYR, which is a drug marketed by Cycle Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the NITYR profile page.

The generic ingredient in NITYR is nitisinone. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
Summary for 209449
Tradename:NITYR
Applicant:Cycle Pharms Ltd
Ingredient:nitisinone
Patents:0
Suppliers and Packaging for NDA: 209449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITYR nitisinone TABLET;ORAL 209449 NDA Cycle Pharmaceuticals Ltd. 70709-000 70709-000-60 1 BOTTLE, PLASTIC in 1 CARTON (70709-000-60) > 60 TABLET in 1 BOTTLE, PLASTIC
NITYR nitisinone TABLET;ORAL 209449 NDA Cycle Pharmaceuticals Ltd. 70709-002 70709-002-60 1 BOTTLE, PLASTIC in 1 CARTON (70709-002-60) > 60 TABLET in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jul 26, 2017TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 26, 2017TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 26, 2017TE:RLD:Yes

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Mallinckrodt
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