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Details for New Drug Application (NDA): 208219
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The generic ingredient in LOTEMAX SM is loteprednol etabonate. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 208219
Tradename: | LOTEMAX SM |
Applicant: | Bausch And Lomb Inc |
Ingredient: | loteprednol etabonate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208219
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 208219
Suppliers and Packaging for NDA: 208219
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOTEMAX SM | loteprednol etabonate | GEL;OPHTHALMIC | 208219 | NDA | Bausch & Lomb Incorporated | 24208-507 | 24208-507-01 | 1 BOTTLE in 1 CARTON (24208-507-01) > .5 g in 1 BOTTLE |
LOTEMAX SM | loteprednol etabonate | GEL;OPHTHALMIC | 208219 | NDA | Bausch & Lomb Incorporated | 24208-507 | 24208-507-02 | 1 BOTTLE in 1 CARTON (24208-507-02) > 5 g in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;OPHTHALMIC | Strength | 0.38% | ||||
Approval Date: | Feb 22, 2019 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Feb 22, 2022 | ||||||||
Regulatory Exclusivity Use: | NEW STRENGTH |
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