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Details for New Drug Application (NDA): 201923
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NDA 201923 describes ILUVIEN, which is a drug marketed by Alimera Sciences Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the ILUVIEN profile page.
The generic ingredient in ILUVIEN is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
The generic ingredient in ILUVIEN is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 201923
| Tradename: | ILUVIEN |
| Applicant: | Alimera Sciences Inc |
| Ingredient: | fluocinolone acetonide |
| Patents: | 5 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201923
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 201923
Suppliers and Packaging for NDA: 201923
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ILUVIEN | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 201923 | NDA | Alimera Sciences, Inc. | 68611-190 | 68611-190-02 | 1 TRAY in 1 CARTON (68611-190-02) > 1 APPLICATOR in 1 TRAY > 1 IMPLANT in 1 APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | IMPLANT;INTRAVITREAL | Strength | 0.19MG | ||||
| Approval Date: | Sep 26, 2014 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Mar 22, 2019 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF DIABETIC MACULAR EDEMA | ||||||||
| Patent: | Start Trial | Patent Expiration: | Apr 26, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF DIABETIC MACULAR EDEMA | ||||||||
| Patent: | Start Trial | Patent Expiration: | Mar 22, 2019 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF DIABETIC MACULAR EDEMA | ||||||||
Expired US Patents for NDA 201923
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alimera Sciences Inc | ILUVIEN | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 201923-001 | Sep 26, 2014 | Start Trial | Start Trial |
| Alimera Sciences Inc | ILUVIEN | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 201923-001 | Sep 26, 2014 | Start Trial | Start Trial |
| Alimera Sciences Inc | ILUVIEN | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 201923-001 | Sep 26, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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