Azelastine Hydrochloride

Product NDC
0832-0290
11-digit product format
008320290
Labeler code
0832
Product ID
0832-0290_d5581ffe-d48a-46f5-8303-691f5195d4a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azelastine Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Upsher-Smith Laboratories, Inc.
Application
ANDA202609
Marketing category
ANDA
Marketing start
2017-03-17
Marketing end
0000-00-00
Substance
AZELASTINE HYDROCHLORIDE
Active strength
137 ug/.137mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record