FDA.reportPublic FDA data

Application 090176

Type
ANDA
Sponsor
BRECKENRIDGE

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
42291-153AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAvKARE, Inc.ANDACurrent
42291-153AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAvKARE, IncANDACurrent
42291-153AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAvKAREANDACurrent
51991-814AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-814AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEBreckenridge PharmaceuticANDACurrent
51991-814AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-814AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-814AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-814AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
63629-2057AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-2057AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-2057AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-2057AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
76519-1222AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEH.J. Harkins Company, Inc.ANDACurrent