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Details for New Drug Application (NDA): 208219
NDA 208219 describes LOTEMAX SM, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from one supplier. Additional details are available on the LOTEMAX SM profile page.
The generic ingredient in LOTEMAX SM is loteprednol etabonate. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
The generic ingredient in LOTEMAX SM is loteprednol etabonate. There are ten drug master file entries for this compound. Two 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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