| Product NDC: | 16590-007 |
| Proprietary Name: | ALREX |
| Non Proprietary Name: | loteprednol etabonate |
| Active Ingredient(s): | 2 mg/mL & nbsp; loteprednol etabonate |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SUSPENSION/ DROPS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-007 |
| Labeler Name: | STAT Rx USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020803 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19980309 |
| Package NDC: | 16590-007-05 |
| Package Description: | 1 BOTTLE, DROPPER in 1 CARTON (16590-007-05) > 5 mL in 1 BOTTLE, DROPPER |
| NDC Code | 16590-007-05 |
| Proprietary Name | ALREX |
| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (16590-007-05) > 5 mL in 1 BOTTLE, DROPPER |
| Product NDC | 16590-007 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | loteprednol etabonate |
| Dosage Form Name | SUSPENSION/ DROPS |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 19980309 |
| Marketing Category Name | NDA |
| Labeler Name | STAT Rx USA LLC |
| Substance Name | LOTEPREDNOL ETABONATE |
| Strength Number | 2 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |