Details for New Drug Application (NDA): 206229
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NDA 206229 describes LILETTA, which is a drug marketed by Medicines360 and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the LILETTA profile page.
The generic ingredient in LILETTA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
The generic ingredient in LILETTA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 206229
| Tradename: | LILETTA |
| Applicant: | Medicines360 |
| Ingredient: | levonorgestrel |
| Patents: | 4 |
Pharmacology for NDA: 206229
| Physiological Effect | Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for 206229
Suppliers and Packaging for NDA: 206229
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LILETTA | levonorgestrel | SYSTEM;INTRAUTERINE | 206229 | NDA | Allergan, Inc. | 0023-5858 | 0023-5858-01 | 1 TRAY in 1 CARTON (0023-5858-01) / 1 INTRAUTERINE DEVICE in 1 TRAY |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;INTRAUTERINE | Strength | 52MG | ||||
| Approval Date: | Feb 26, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 29, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR UP TO 5 YEARS IN PATIENTS WHO CHOOSE INTRAUTERINE CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 22, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD FOR PREVENTION OF PREGNANCY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Oct 24, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR PREVENTION OF PREGNANCY | ||||||||
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