FDA.reportPublic FDA data

Application 206781

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9843DEXAMETHASONE SODIUM PHOSPHATEdexamethasone sodium phosphateHenry Schein, Inc.ANDACurrent
0404-9843DEXAMETHASONE SODIUM PHOSPHATEdexamethasone sodium phosphateHenry Schein, Inc.ANDACurrent
50090-3300DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEA-S Medication SolutionsANDACurrent
50090-3300DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEA-S Medication SolutionsANDACurrent
50090-3300DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEA-S Medication SolutionsANDACurrent
51662-1432DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1432DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-238DEXAMETHASONE SODIUM PHOSPHATEdexamethasone sodium phosphateGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-239DEXAMETHASONE SODIUM PHOSPHATEdexamethasone sodium phosphateGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-239DEXAMETHASONE SODIUM PHOSPHATEdexamethasone sodium phosphateGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-239DEXAMETHASONE SODIUM PHOSPHATEdexamethasone sodium phosphateGeneral Injectables & Vaccines, Inc.ANDACurrent
55150-237DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEAuroMedics Pharma LLCANDACurrent
55150-237DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEAuroMedics Pharma LLCANDACurrent
55150-238DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEAuroMedics Pharma LLCANDACurrent
55150-238DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEAuroMedics Pharma LLCANDACurrent
55150-239DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEAuroMedics Pharma LLCANDACurrent
55150-239DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEAuroMedics Pharma LLCANDACurrent
55154-8338DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATECardinal HealthANDACurrent
68071-1866DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATENuCare Pharmaceuticals,Inc.ANDACurrent
70518-3119DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEREMEDYREPACK INC.ANDACurrent
70529-053LudaxineDexamethasone Sodium Phosphate, Bupivacaine HydrochlorideIT3 Medical LLCANDACurrent
70529-053LudaxineDexamethasone Sodium Phosphate, Bupivacaine HydrochlorideIT3 Medical LLCANDACurrent
70529-053LudaxineDexamethasone Sodium Phosphate, Bupivacaine HydrochlorideIT3 Medical LLCANDACurrent
71872-7021DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLCANDACurrent
71872-7021DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLCANDACurrent
71872-7092DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLCANDACurrent
71872-7092DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLCANDACurrent
71872-7128DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLCANDACurrent
71872-7128DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLCANDACurrent
76420-077DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.ANDACurrent
76420-077DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10594ORIG2015-12-03