FDA.reportPublic FDA data

Application 207183

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.25%NoNo
002BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4516Bupivacaine HydrochlorideBupivacaine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4516Bupivacaine HydrochlorideBupivacaine HydrochlorideA-S Medication SolutionsANDACurrent
51662-1581BUPIVACAINE HCIBUPIVACAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
55150-249Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-249Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-249Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-250Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-250Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-250Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
70529-006Burapren 0.5%Bupivacaine HydrochlorideIT3 Medical LLCANDACurrent
70529-006Burapren 0.5%Bupivacaine HydrochlorideIT3 Medical LLCANDACurrent
70529-006Burapren 0.5%Bupivacaine HydrochlorideIT3 Medical LLCANDACurrent
71872-7133Bupivacaine HydrochlorideBupivacaine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7133Bupivacaine HydrochlorideBupivacaine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7270Bupivacaine HydrochlorideBupivacaine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent