Details for New Drug Application (NDA): 200738
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NDA 200738 describes LOTEMAX, which is a drug marketed by Bausch And Lomb Inc, Bausch And Lomb, and Pharmos, and is included in five NDAs. It is available from four suppliers. There are two patents protecting this drug. Additional details are available on the LOTEMAX profile page.
The generic ingredient in LOTEMAX is loteprednol etabonate. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
The generic ingredient in LOTEMAX is loteprednol etabonate. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 200738
| Tradename: | LOTEMAX |
| Applicant: | Bausch And Lomb |
| Ingredient: | loteprednol etabonate |
| Patents: | 0 |
Pharmacology for NDA: 200738
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 200738
Suppliers and Packaging for NDA: 200738
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOTEMAX | loteprednol etabonate | OINTMENT;OPHTHALMIC | 200738 | NDA | Bausch & Lomb Incorporated | 24208-443 | 24208-443-01 | 1 TUBE in 1 CARTON (24208-443-01) / 1 g in 1 TUBE |
| LOTEMAX | loteprednol etabonate | OINTMENT;OPHTHALMIC | 200738 | NDA | Bausch & Lomb Incorporated | 24208-443 | 24208-443-35 | 1 TUBE in 1 CARTON (24208-443-35) / 3.5 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Apr 15, 2011 | TE: | RLD: | Yes | |||||
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