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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 021225

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NDA 021225 describes MIRENA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the MIRENA profile page.

The generic ingredient in MIRENA 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 021225

Tradename:	MIRENA
Applicant:	Bayer Hlthcare
Ingredient:	levonorgestrel
Patents:	2
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021225

Physiological Effect	Inhibit Ovum Fertilization

Medical Subject Heading (MeSH) Categories for 021225

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

Suppliers and Packaging for NDA: 021225

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MIRENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	021225	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-423	50419-423-01	1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-01)
MIRENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	021225	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-423	50419-423-08	1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INTRAUTERINE DEVICE;INTRAUTERINE			Strength	52MG
Approval Date:	Dec 6, 2000	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	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:	⤷ Try a Trial	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 021225

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MIRENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	021225-001	Dec 6, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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