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-five 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

Pharmacology for NDA: 208224

Physiological Effect	Inhibit Ovum Fertilization

Medical Subject Heading (MeSH) Categories for 208224

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

Suppliers and Packaging for NDA: 208224

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-424	50419-424-01	1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)
KYLEENA	levonorgestrel	SYSTEM;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:	RX	Dosage:	SYSTEM;INTRAUTERINE			Strength	19.5MG
Approval Date:	Sep 16, 2016	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 16, 2029	Product 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:	⤷ Sign Up	Patent Expiration:	Feb 7, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Sep 14, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	A METHOD OF PREVENTING PREGNANCY BY PROVIDING AN INTRAUTERINE SYSTEM (IUS), HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND MOVING A SLIDER IN THE HANDLE TO RELEASE THE IUS WITHIN THE UTERUS

Expired US Patents for NDA 208224

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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