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 are three patents 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. Thirty-four suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
The generic ingredient in KYLEENA 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 208224
| Tradename: | KYLEENA |
| Applicant: | Bayer Hlthcare |
| Ingredient: | levonorgestrel |
| Patents: | 3 |
Pharmacology for NDA: 208224
| Physiological Effect | Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for 208224
Suppliers and Packaging for NDA: 208224
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KYLEENA | levonorgestrel | SYSTEM;INTRAUTERINE | 208224 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-424 | 50419-424-01 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01) |
| KYLEENA | levonorgestrel | SYSTEM;INTRAUTERINE | 208224 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-424 | 50419-424-08 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;INTRAUTERINE | Strength | 19.5MG | ||||
| Approval Date: | Sep 16, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 10,561,524 | 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: | 11,628,088 | Patent Expiration: | Feb 7, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,850,182 | 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 208224
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | KYLEENA | levonorgestrel | SYSTEM;INTRAUTERINE | 208224-001 | Sep 16, 2016 | 7,252,839 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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