FDA.reportPublic FDA data

Application 077954

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDESPRAY, METERED;NASALEQ 0.125MG BASE/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2330Azelastine Hydrochlorideazelastine hydrochlorideA-S Medication SolutionsANDACurrent
50090-2330Azelastine Hydrochlorideazelastine hydrochlorideA-S Medication SolutionsANDACurrent
50090-2330Azelastine Hydrochlorideazelastine hydrochlorideA-S Medication SolutionsANDACurrent
53002-1279Azelastine Hydrochlorideazelastine hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
60505-0833Azelastine Hydrochlorideazelastine hydrochlorideApotex Corp.ANDACurrent
60505-0833Azelastine Hydrochlorideazelastine hydrochlorideApotex Corp.ANDACurrent
60505-0833Azelastine Hydrochlorideazelastine hydrochlorideApotex Corp.ANDACurrent
60505-0833Azelastine Hydrochlorideazelastine hydrochlorideApotex Corp.ANDACurrent
68071-2497Azelastine Hydrochlorideazelastine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
71205-449Azelastine Hydrochlorideazelastine hydrochlorideProficient Rx LPANDACurrent
71205-449Azelastine Hydrochlorideazelastine hydrochlorideProficient Rx LPANDACurrent
71205-449Azelastine Hydrochlorideazelastine hydrochlorideProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31312ORIG2009-05-06
31311ORIG2008-05-05