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Argus Health
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Generated: April 21, 2018

DrugPatentWatch Database Preview

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. Eighteen 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
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 021225
Ingredient-typeProgesterone Congeners
Physiological EffectInhibit Ovum Fertilization
Medical Subject Heading (MeSH) Categories for 021225
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 N 50419-423-08
MIRENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 021225 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-423 N 50419-423-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INTRAUTERINE DEVICE;INTRAUTERINEStrength52MG
Approval Date:Dec 6, 2000TE:RLD:Yes
Patent:➤ Try a Free TrialPatent 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
Patent:➤ Try a Free TrialPatent Expiration:Apr 1, 2031Product Flag?YSubstance Flag?Delist Request?

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US Department of Justice
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