| Product NDC: | 61314-308 |
| 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: | 61314-308 |
| Labeler Name: | Sandoz Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA202305 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130321 |
| Package NDC: | 61314-308-02 |
| Package Description: | 1 BOTTLE, PLASTIC in 1 CARTON (61314-308-02) > 6 mL in 1 BOTTLE, PLASTIC |
| NDC Code | 61314-308-02 |
| Proprietary Name | Azelastine Hydrochloride |
| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (61314-308-02) > 6 mL in 1 BOTTLE, PLASTIC |
| Product NDC | 61314-308 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | azelastine hydrochloride |
| Dosage Form Name | SOLUTION/ DROPS |
| Route Name | INTRAOCULAR |
| Start Marketing Date | 20130321 |
| Marketing Category Name | ANDA |
| Labeler Name | Sandoz Inc |
| Substance Name | AZELASTINE HYDROCHLORIDE |
| Strength Number | .5 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] |