Product NDC: | 0037-0243 |
Proprietary Name: | Astepro |
Non Proprietary Name: | Azelastine Hydrochloride |
Active Ingredient(s): | 205.5 ug/1 & nbsp; Azelastine Hydrochloride |
Administration Route(s): | NASAL |
Dosage Form(s): | SPRAY, METERED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0037-0243 |
Labeler Name: | Meda Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022371 |
Marketing Category: | NDA |
Start Marketing Date: | 20091012 |
Package NDC: | 0037-0243-04 |
Package Description: | 1 BOTTLE, SPRAY in 1 BOX (0037-0243-04) > 22 SPRAY, METERED in 1 BOTTLE, SPRAY |
NDC Code | 0037-0243-04 |
Proprietary Name | Astepro |
Package Description | 1 BOTTLE, SPRAY in 1 BOX (0037-0243-04) > 22 SPRAY, METERED in 1 BOTTLE, SPRAY |
Product NDC | 0037-0243 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Azelastine Hydrochloride |
Dosage Form Name | SPRAY, METERED |
Route Name | NASAL |
Start Marketing Date | 20091012 |
Marketing Category Name | NDA |
Labeler Name | Meda Pharmaceuticals Inc. |
Substance Name | AZELASTINE HYDROCHLORIDE |
Strength Number | 205.5 |
Strength Unit | ug/1 |
Pharmaceutical Classes | Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] |