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Generated: November 15, 2018

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Details for New Drug Application (NDA): 203159

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NDA 203159 describes SKYLA, 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 SKYLA profile page.

The generic ingredient in SKYLA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 203159
Tradename:SKYLA
Applicant:Bayer Hlthcare
Ingredient:levonorgestrel
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 203159
Ingredient-typeProgesterone Congeners
Physiological EffectInhibit Ovum Fertilization
Medical Subject Heading (MeSH) Categories for 203159
Suppliers and Packaging for NDA: 203159
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SKYLA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 203159 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-422 50419-422-01 1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01)
SKYLA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 203159 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-422 50419-422-08 1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INTRAUTERINE DEVICE;INTRAUTERINEStrength13.5MG
Approval Date:Jan 9, 2013TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 13, 2023Product Flag?YSubstance Flag?Delist Request?
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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