FDA.reportPublic FDA data

Application 078492

Type
ANDA
Sponsor
WOCKHARDT BIO AG

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
45865-602FluticasoneFluticasone PropionateMedsource PharmaceuticalsANDACurrent
50436-2640FluticasoneFluticasone PropionateUnit Dose ServicesANDACurrent
55700-680FLUTICASONEfluticasone propionateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-680FLUTICASONEfluticasone propionateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-680FLUTICASONEfluticasone propionateLake Erie Medical DBA Quality Care Products LLCANDACurrent
60432-264FLUTICASONEfluticasone propionateMorton Grove Pharmaceuticals, Inc.ANDACurrent
61919-004FLUTICASONEFLUTICASONEDirect RXANDACurrent
61919-004FLUTICASONEFLUTICASONEDirect RXANDACurrent
68071-1638FluticasoneFluticasone PropionateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1638FluticasoneFluticasone PropionateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7788FLUTICASONEfluticasone propionatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7788FLUTICASONEfluticasone propionatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7788FLUTICASONEfluticasone propionatePreferred Pharmaceuticals Inc.ANDACurrent
71205-443FLUTICASONEfluticasone propionateProficient Rx LPANDACurrent
71205-443FLUTICASONEfluticasone propionateProficient Rx LPANDACurrent