FDA.reportPublic FDA data

Application 084916

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTIONEQ 4MG PHOSPHATE/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0414Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEA-S Medication SolutionsANDACurrent
50090-0627Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEA-S Medication SolutionsANDACurrent
51662-1370DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1370DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1370DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
55154-9364Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATECardinal HealthANDACurrent
55154-9364Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATECardinal Health 107, LLCANDACurrent
63323-165Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLCANDACurrent
63323-165Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLCANDACurrent
63323-165Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLCANDACurrent
68071-4580Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATENuCare Pharmaceuticals,Inc.ANDACurrent
70518-0621Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEREMEDYREPACK INC.ANDACurrent
70518-0872Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEREMEDYREPACK INC.ANDACurrent
70529-112Neuromaquel Neuroma/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
70529-112Neuromaquel Neuroma/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
70529-112Neuromaquel Neuroma/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
70529-118Cortaren Corticosteroid/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
70529-118Cortaren Corticosteroid/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
70529-118Cortaren Corticosteroid/Anti-Inflammatory SystemDEXAMETHASONE SODIUM PHOSPHATEIT3 Medical LLCANDACurrent
81565-202Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEPhlow CorporationANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9243SUPPL2015-07-28
18506SUPPL2015-07-27