Details for New Drug Application (NDA): 218158
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NDA 218158 describes BYQLOVI, which is a drug marketed by Harrow Eye 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 BYQLOVI profile page.
The generic ingredient in BYQLOVI is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
The generic ingredient in BYQLOVI is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 218158
| Tradename: | BYQLOVI |
| Applicant: | Harrow Eye |
| Ingredient: | clobetasol propionate |
| Patents: | 2 |
Pharmacology for NDA: 218158
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 218158
Suppliers and Packaging for NDA: 218158
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BYQLOVI | clobetasol propionate | SUSPENSION/DROPS;OPHTHALMIC | 218158 | NDA | Eyenovia, Inc. | 81046-0319 | 81046-0319-1 | 1 BOTTLE, DROPPER in 1 CARTON (81046-0319-1) / 3.5 mL in 1 BOTTLE, DROPPER |
| BYQLOVI | clobetasol propionate | SUSPENSION/DROPS;OPHTHALMIC | 218158 | NDA | Harrow Eye, LLC | 82667-021 | 82667-021-00 | 1 BOTTLE, PLASTIC in 1 CARTON (82667-021-00) / 3.5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.05% | ||||
| Approval Date: | Mar 4, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 4, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 9, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 9, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF INFLAMMATION | ||||||||
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