Details for New Drug Application (NDA): 210933
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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: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | May 3, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | May 3, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? |
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