FDA.reportPublic FDA data

Application 077538

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATESPRAY, METERED;NASAL0.05MG/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-653Fluticasone PropionateFluticasone PropionateBlenheim Pharmacal, Inc.ANDACurrent
50090-0968Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-0968Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-0968Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-2267Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-2267Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-2267Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-3679Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-3679Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
53002-7691Fluticasone PropionateFluticasone PropionateRPK Pharmaceuticals, Inc.ANDACurrent
53002-7691Fluticasone PropionateFluticasone PropionateRPK Pharmaceuticals, Inc.ANDACurrent
55700-714Fluticasone PropionateFluticasone PropionateQuality Care Products, LLCANDACurrent
55700-714Fluticasone PropionateFluticasone PropionateQuality Care Products, LLCANDACurrent
59088-392TicanaseFluticasone PropionatePureTek CorporationANDACurrent
59088-392TicanaseFluticasone PropionatePureTek CorporationANDACurrent
60429-195Fluticasone PropionateFluticasone PropionateGolden State Medical Supply, Inc.ANDACurrent
60429-195Fluticasone PropionateFluticasone PropionateGolden State Medical Supply, Inc.ANDACurrent
60429-195Fluticasone PropionateFluticasone PropionateGolden State Medical SupplyANDACurrent
60429-195Fluticasone PropionateFluticasone PropionateGolden State Medical Supply, Inc.ANDACurrent
60429-195Fluticasone PropionateFluticasone PropionateGolden State Medical Supply, Inc.ANDACurrent
60505-0829Fluticasone PropionateFluticasone PropionateApotex Corp.ANDACurrent
60505-0829Fluticasone PropionateFluticasone PropionateApotex Corp.ANDACurrent
60505-0829Fluticasone PropionateFluticasone PropionateApotex Corp.ANDACurrent
60505-0829Fluticasone PropionateFluticasone PropionateApotex Corp.ANDACurrent
60505-0829Fluticasone PropionateFluticasone PropionateApotex Corp.ANDACurrent
60505-0829Fluticasone PropionateFluticasone PropionateApotex Corp.ANDACurrent
60505-0829Fluticasone PropionateFluticasone PropionateApotex Corp.ANDACurrent
60505-0847Fluticasone PropionateFluticasone PropionateApotex Corp.ANDACurrent
60505-0847Fluticasone PropionateFluticasone PropionateApotex Corp.ANDACurrent
63187-638Fluticasone PropionateFluticasone PropionateProficient Rx LPANDACurrent
63187-638Fluticasone PropionateFluticasone PropionateProficient Rx LPANDACurrent
63187-638Fluticasone PropionateFluticasone PropionateProficient Rx LPANDACurrent
63187-638Fluticasone PropionateFluticasone PropionateProficient Rx LPANDACurrent
68071-2582Fluticasone PropionateFluticasone PropionateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9678Fluticasone PropionateFluticasone PropionatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9678Fluticasone PropionateFluticasone PropionatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9678Fluticasone PropionateFluticasone PropionatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9678Fluticasone PropionateFluticasone PropionatePreferred Pharmaceuticals, Inc.ANDACurrent
69621-392TicasprayFluticasone PropionateShoreline Pharmaceuticals, Inc.ANDACurrent
70518-1655Fluticasone PropionateFluticasone PropionateREMEDYREPACK INC.ANDACurrent
70518-1655Fluticasone PropionateFluticasone PropionateREMEDYREPACK INC.ANDACurrent
70518-1655Fluticasone PropionateFluticasone PropionateREMEDYREPACK INC.ANDACurrent
72189-004Fluticasone PropionateFluticasone PropionateDirect_RXANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43125ORIG2011-12-14