Details for New Drug Application (NDA): 022388
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NDA 022388 describes ACUVUE THERAVISION WITH KETOTIFEN, which is a drug marketed by Johnson Johnson Visn and is included in one NDA. There are two patents protecting this drug. Additional details are available on the ACUVUE THERAVISION WITH KETOTIFEN profile page.
The generic ingredient in ACUVUE THERAVISION WITH KETOTIFEN is ketotifen fumarate. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
The generic ingredient in ACUVUE THERAVISION WITH KETOTIFEN is ketotifen fumarate. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
Summary for 022388
| Tradename: | ACUVUE THERAVISION WITH KETOTIFEN |
| Applicant: | Johnson Johnson Visn |
| Ingredient: | ketotifen fumarate |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 022388
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | DRUG-ELUTING CONTACT LENS;OPHTHALMIC | Strength | EQ 19MCG BASE | ||||
| Approval Date: | Feb 25, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 25, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 27, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 27, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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