| Product NDC: | 60505-0578 |
| Proprietary Name: | AZELASTINE HYDROCHLORIDE |
| Non Proprietary Name: | AZELASTINE HYDROCHLORIDE |
| Active Ingredient(s): | .5 mg/mL & nbsp; AZELASTINE HYDROCHLORIDE |
| Administration Route(s): | INTRAOCULAR |
| Dosage Form(s): | SOLUTION/ DROPS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 60505-0578 |
| Labeler Name: | Apotex Corp. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078621 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20091201 |
| Package NDC: | 60505-0578-4 |
| Package Description: | 1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4) > 6 mL in 1 BOTTLE, PLASTIC |
| NDC Code | 60505-0578-4 |
| Proprietary Name | AZELASTINE HYDROCHLORIDE |
| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4) > 6 mL in 1 BOTTLE, PLASTIC |
| Product NDC | 60505-0578 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | AZELASTINE HYDROCHLORIDE |
| Dosage Form Name | SOLUTION/ DROPS |
| Route Name | INTRAOCULAR |
| Start Marketing Date | 20091201 |
| Marketing Category Name | ANDA |
| Labeler Name | Apotex Corp. |
| Substance Name | AZELASTINE HYDROCHLORIDE |
| Strength Number | .5 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] |