Details for New Drug Application (NDA): 210331
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NDA 210331 describes YUTIQ, which is a drug marketed by Alimera Sciences Inc and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the YUTIQ profile page.
The generic ingredient in YUTIQ is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
The generic ingredient in YUTIQ is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 210331
| Tradename: | YUTIQ |
| Applicant: | Alimera Sciences Inc |
| Ingredient: | fluocinolone acetonide |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210331
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210331
Suppliers and Packaging for NDA: 210331
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331 | NDA | Alimera Sciences, Inc. | 68611-180 | 68611-180-01 | 1 POUCH in 1 CARTON (68611-180-01) / 1 APPLICATOR in 1 POUCH / 1 IMPLANT in 1 APPLICATOR |
| YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331 | NDA | EyePoint Pharmaceuticals, Inc | 71879-136 | 71879-136-01 | 1 POUCH in 1 BOX, UNIT-DOSE (71879-136-01) / 1 APPLICATOR in 1 POUCH / 1 IMPLANT in 1 APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | IMPLANT;INTRAVITREAL | Strength | 0.18MG | ||||
| Approval Date: | Oct 12, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 12, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF INJECTING AN IMPLANT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 12, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 210331
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