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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 is one patent 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

Summary for NDA: 208224

Pharmacology for NDA: 208224

Ingredient-typeProgesterone Congeners
Physiological EffectInhibit Ovum Fertilization

Suppliers and Packaging for NDA: 208224

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INTRAUTERINE DEVICE;INTRAUTERINE 208224 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-424 50419-424-01 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)
INTRAUTERINE DEVICE;INTRAUTERINE 208224 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-424 50419-424-08 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-08)

Summary for product number 001

Approval Date:Sep 16, 2016TE:RLD:Yes
Patent:7,252,839Patent Expiration:Nov 13, 2023Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Sep 16, 2019
Regulatory Exclusivity Use:NEW PRODUCT

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.