Details for New Drug Application (NDA): 210933
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NDA 210933 describes EYSUVIS, which is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug. Additional details are available on the EYSUVIS profile page.
The generic ingredient in EYSUVIS is loteprednol etabonate. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
The generic ingredient in EYSUVIS is loteprednol etabonate. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 210933
| Tradename: | EYSUVIS |
| Applicant: | Alcon Labs Inc |
| Ingredient: | loteprednol etabonate |
| Patents: | 16 |
Pharmacology for NDA: 210933
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210933
Suppliers and Packaging for NDA: 210933
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EYSUVIS | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 210933 | NDA | ALCON LABORATORIES, INC. | 71571-333 | 71571-333-01 | 1 BOTTLE, DROPPER in 1 CARTON (71571-333-01) / 1 mL in 1 BOTTLE, DROPPER |
| EYSUVIS | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 210933 | NDA | ALCON LABORATORIES, INC. | 71571-333 | 71571-333-24 | 2.4 mL in 1 BOTTLE, DROPPER (71571-333-24) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.25% | ||||
| Approval Date: | Oct 26, 2020 | TE: | RLD: | Yes | |||||
| Patent: | 10,058,511 | Patent Expiration: | May 3, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER | ||||||||
| Patent: | 10,646,436 | Patent Expiration: | May 3, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,688,045 | Patent Expiration: | May 3, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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