Astepro

Product NDC

0037-0242

11-digit product format

000370242

Labeler code

0037

Product ID

0037-0242_f3845546-7fac-4305-acdc-b41155408f62

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Azelastine Hydrochloride

Dosage form

SPRAY, METERED

Route

NASAL

Labeler

Meda Pharmaceuticals

Application

NDA022203

Marketing category

NDA

Marketing start

2009-10-12

Marketing end

2020-12-31

Substance

AZELASTINE HYDROCHLORIDE

Active strength

137 ug/1

Pharmacologic classes

Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record