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] |