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. Thirty-four suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
The generic ingredient in MIRENA 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 021225
| Tradename: | MIRENA |
| Applicant: | Bayer Hlthcare |
| Ingredient: | levonorgestrel |
| Patents: | 2 |
Pharmacology for NDA: 021225
| Physiological Effect | Inhibit 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 | SYSTEM;INTRAUTERINE | 021225 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-423 | 50419-423-01 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-01) |
| MIRENA | levonorgestrel | SYSTEM;INTRAUTERINE | 021225 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-423 | 50419-423-08 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;INTRAUTERINE | Strength | 52MG | ||||
| Approval Date: | Dec 6, 2000 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | 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 021225
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | MIRENA | levonorgestrel | SYSTEM;INTRAUTERINE | 021225-001 | Dec 6, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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