Details for New Drug Application (NDA): 216675
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The generic ingredient in MIEBO is perfluorohexyloctane. One supplier is listed for this compound. Additional details are available on the perfluorohexyloctane profile page.
Summary for 216675
Tradename: | MIEBO |
Applicant: | Bausch And Lomb Inc |
Ingredient: | perfluorohexyloctane |
Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216675
Generic Entry Date for 216675*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
SOLUTION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 216675
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675 | NDA | Bausch & Lomb Incorporated | 24208-377 | 24208-377-01 | 1 BOTTLE in 1 CARTON (24208-377-01) / 3 mg in 1 BOTTLE |
MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675 | NDA | Bausch & Lomb Incorporated | 24208-377 | 24208-377-05 | 1 BOTTLE in 1 CARTON (24208-377-05) / 3 mg in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1.338GM/ML | ||||
Approval Date: | May 18, 2023 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | May 18, 2028 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 12, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 12, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
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