FDA.reportPublic FDA data

Application 040431

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATETABLET;ORAL0.1MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-7033Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-7033Fludrocortisone AcetateFLUDROCORTISONE ACETATEImpax GenericsANDACurrent
0115-7033Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-7033Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-7033Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-7033Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-7033Fludrocortisone AcetateFLUDROCORTISONE ACETATEImpax GenericsANDACurrent
0615-6562Fludrocortisone AcetateFLUDROCORTISONE ACETATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6562Fludrocortisone AcetateFLUDROCORTISONE ACETATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42291-529FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATEAvKARE, Inc.ANDACurrent
42291-529FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATEAvKARE, Inc.ANDACurrent
42291-529FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATEAvKAREANDACurrent
42291-764Fludrocortisone AcetateFLUDROCORTISONE ACETATEAvKAREANDACurrent
42291-764Fludrocortisone AcetateFLUDROCORTISONE ACETATEAvKAREANDACurrent
50268-330FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATEAvPAKANDACurrent
50268-330FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATEAvPAKANDACurrent
50268-330FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATEAvPAKANDACurrent
50268-330FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATEAvPAKANDACurrent
55154-6645Fludrocortisone AcetateFludrocortisone AcetateCardinal HealthANDACurrent
55154-6645Fludrocortisone AcetateFludrocortisone AcetateCardinal HealthANDACurrent
55154-6645Fludrocortisone AcetateFludrocortisone AcetateCardinal HealthANDACurrent
55154-6645Fludrocortisone AcetateFludrocortisone AcetateCardinal HealthANDACurrent
55154-6645Fludrocortisone AcetateFludrocortisone AcetateCardinal Health 107, LLCANDACurrent
68084-288Fludrocortisone AcetateFludrocortisone AcetateAmerican Health PackagingANDACurrent
68084-288Fludrocortisone AcetateFludrocortisone AcetateAmerican Health PackagingANDACurrent
68084-288Fludrocortisone AcetateFludrocortisone AcetateAmerican Health PackagingANDACurrent
68084-288Fludrocortisone AcetateFludrocortisone AcetateAmerican Health PackagingANDACurrent
69238-7033Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals NY LLCANDACurrent
69238-7033Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals NY LLCANDACurrent
71335-0976Fludrocortisone AcetateFLUDROCORTISONE ACETATEBryant Ranch PrepackANDACurrent
71335-0976Fludrocortisone AcetateFLUDROCORTISONE ACETATEBryant Ranch PrepackANDACurrent
71335-0976Fludrocortisone AcetateFLUDROCORTISONE ACETATEBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7660ORIG2003-04-09