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Last Updated: April 22, 2024

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-four 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
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 TrialPatent Expiration:Sep 16, 2029Product 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 TrialPatent Expiration:Feb 7, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Sep 14, 2029Product Flag?YSubstance 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 203159

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare SKYLA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 203159-001 Jan 9, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare SKYLA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 203159-001 Jan 9, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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