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Last Updated: March 28, 2024

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 five 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-four 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:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 208224
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
Patent:⤷  Try a TrialPatent Expiration:Sep 16, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM (IUS) BY DETERMINING A DEPTH OF THE UTERUS, HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE IUS INTO THE UTERUS
Patent:⤷  Try a TrialPatent Expiration:Apr 1, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Feb 7, 2027Product Flag?YSubstance Flag?Delist Request?

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