Details for New Drug Application (NDA): 020803
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The generic ingredient in ALREX is loteprednol etabonate. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 020803
| Tradename: | ALREX |
| Applicant: | Bausch And Lomb |
| Ingredient: | loteprednol etabonate |
| Patents: | 0 |
Pharmacology for NDA: 020803
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 020803
Suppliers and Packaging for NDA: 020803
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALREX | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 020803 | NDA | Bausch & Lomb Incorporated | 24208-353 | 24208-353-01 | 1 BOTTLE, DROPPER in 1 CARTON (24208-353-01) / 1 mL in 1 BOTTLE, DROPPER |
| ALREX | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 020803 | NDA | Bausch & Lomb Incorporated | 24208-353 | 24208-353-05 | 1 BOTTLE, DROPPER in 1 CARTON (24208-353-05) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.2% | ||||
| Approval Date: | Mar 9, 1998 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020803
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch And Lomb | ALREX | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 020803-001 | Mar 9, 1998 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bausch And Lomb | ALREX | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 020803-001 | Mar 9, 1998 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bausch And Lomb | ALREX | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 020803-001 | Mar 9, 1998 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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