FDA.reportPublic FDA data

Application 201846

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDESPRAY, METERED;NASALEQ 0.1876MG BASE/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-0848Azelastine HydrochlorideAzelastine HydrochlorideApotex Corp.ANDACurrent
60505-0848Azelastine HydrochlorideAzelastine HydrochlorideApotex Corp.ANDACurrent
60505-0848Azelastine HydrochlorideAzelastine HydrochlorideApotex Corp.ANDACurrent
60505-0848Azelastine HydrochlorideAzelastine HydrochlorideApotex Corp.ANDACurrent
68071-2498Azelastine HydrochlorideAzelastine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43375ORIG2012-10-09