Details for New Drug Application (NDA): 210565
✉ Email this page to a colleague
The generic ingredient in INVELTYS 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 210565
Tradename: | INVELTYS |
Applicant: | Alcon Labs Inc |
Ingredient: | loteprednol etabonate |
Patents: | 12 |
Pharmacology for NDA: 210565
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210565
Suppliers and Packaging for NDA: 210565
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INVELTYS | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 210565 | NDA | ALCON LABORATORIES, INC. | 71571-121 | 71571-121-20 | 2.8 mL in 1 BOTTLE, DROPPER (71571-121-20) |
INVELTYS | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 210565 | NDA | ALCON LABORATORIES, INC. | 71571-121 | 71571-121-28 | 1 BOTTLE, DROPPER in 1 CARTON (71571-121-28) / 2.8 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 1% | ||||
Approval Date: | Aug 22, 2018 | 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? |
Complete Access Available with Subscription