Details for New Drug Application (NDA): 210565
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NDA 210565 describes INVELTYS, which is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the INVELTYS profile page.
The generic ingredient in INVELTYS is loteprednol etabonate. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
The generic ingredient in INVELTYS is loteprednol etabonate. There are ten drug master file entries for this compound. Seven 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 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | Patent Expiration: | May 3, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 3, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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