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Generated: November 16, 2018

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Details for New Drug Application (NDA): 208224

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NDA 208224 describes KYLEENA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the KYLEENA profile page.

The generic ingredient in KYLEENA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 208224
Tradename:KYLEENA
Applicant:Bayer Hlthcare
Ingredient:levonorgestrel
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 208224
Ingredient-typeProgesterone Congeners
Physiological EffectInhibit Ovum Fertilization
Medical Subject Heading (MeSH) Categories for 208224
Suppliers and Packaging for NDA: 208224
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-424 50419-424-01 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)
KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-424 50419-424-08 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INTRAUTERINE DEVICE;INTRAUTERINEStrength19.5MG
Approval Date:Sep 16, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 16, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Nov 13, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Sep 16, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM BY HOLDING AN INSERTER HANDLE WITH ONE HAND, ADVANCING THE INSERTER THROUGH THE CERVIX AND INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE INTRAUTERINE SYSTEM

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