FDA.reportPublic FDA data

Application 077570

Type
ANDA
Sponsor
HI TECH PHARMA

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
21695-704Fluticasone PropionateFluticasone PropionateRebel Distributors CorpANDACurrent
49999-982Fluticasone PropionateFluticasone PropionateLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50090-2484Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-2484Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-2484Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-2557Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-2557Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-3513Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50090-4410Fluticasone PropionateFluticasone PropionateA-S Medication SolutionsANDACurrent
50383-700Fluticasone PropionateFluticasone PropionateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-700Fluticasone PropionateFluticasone PropionateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-700Fluticasone PropionateFluticasone PropionateAkornANDACurrent
50436-9992Fluticasone PropionateFluticasone PropionateUnit Dose ServicesANDACurrent
53002-7690Fluticasone PropionateFluticasone PropionateRPK Pharmaceuticals, Inc.ANDACurrent
53002-7690Fluticasone PropionateFluticasone PropionateRPK Pharmaceuticals, Inc.ANDACurrent
53002-7692Fluticasone PropionateFluticasone PropionateRPK Pharmaceuticals, Inc.ANDACurrent
61919-620FLUTICASONEFLUTICASONEDirect RXANDACurrent
63187-021Fluticasone PropionateFluticasone PropionateProficient Rx LPANDACurrent
63187-021Fluticasone PropionateFluticasone PropionateProficient Rx LPANDACurrent
63187-021Fluticasone PropionateFluticasone PropionateProficient Rx LPANDACurrent
68071-4156Fluticasone PropionateFluticasone PropionateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4156Fluticasone PropionateFluticasone PropionateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9925Fluticasone PropionateFluticasone PropionatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9925Fluticasone PropionateFluticasone PropionatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9925Fluticasone PropionateFluticasone PropionatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9925Fluticasone PropionateFluticasone PropionatePreferred Pharmaceuticals, Inc.ANDACurrent
69306-016Fluticasone PropionateFluticasone PropionateDoc RxANDACurrent
69306-016Fluticasone PropionateFluticasone PropionateDoc RxANDACurrent
69306-016Fluticasone PropionateFluticasone PropionateDoc RxANDACurrent
70518-0137Fluticasone PropionateFluticasone PropionateREMEDYREPACK INC.ANDACurrent
76420-106Fluticasone PropionateFluticasone PropionateAsclemed USA, Inc.ANDACurrent
76420-106Fluticasone PropionateFluticasone PropionateAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43127ORIG2012-05-09
44357ORIG2008-01-30