| Product NDC: | 60505-0584 |
| Proprietary Name: | Epinastine Hydrochloride |
| Non Proprietary Name: | Epinastine Hydrochloride |
| Active Ingredient(s): | .5 mg/mL & nbsp; Epinastine Hydrochloride |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 60505-0584 |
| Labeler Name: | Apotex Corp. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA090919 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20111031 |
| Package NDC: | 60505-0584-1 |
| Package Description: | 1 BOTTLE, PLASTIC in 1 CARTON (60505-0584-1) > 5 mL in 1 BOTTLE, PLASTIC |
| NDC Code | 60505-0584-1 |
| Proprietary Name | Epinastine Hydrochloride |
| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (60505-0584-1) > 5 mL in 1 BOTTLE, PLASTIC |
| Product NDC | 60505-0584 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Epinastine Hydrochloride |
| Dosage Form Name | SOLUTION |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 20111031 |
| Marketing Category Name | ANDA |
| Labeler Name | Apotex Corp. |
| Substance Name | EPINASTINE HYDROCHLORIDE |
| Strength Number | .5 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] |