FDA.reportPublic FDA data

Application 203895

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.25%NoNo
002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%NoNo
003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.75%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-167Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-167Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-167Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-168Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-168Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-168Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-169Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-169Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-169Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-170Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-170Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-170Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-171Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-171Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-171Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-172Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-172Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-172Bupivacaine HydrochlorideBupivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
70518-2360Bupivacaine HydrochlorideBupivacaine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2360Bupivacaine HydrochlorideBupivacaine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2360Bupivacaine HydrochlorideBupivacaine HydrochlorideREMEDYREPACK INC.ANDACurrent
70529-008Burapren 0.75%Bupivacaine HydrochlorideIT3 Medical LLCANDACurrent
70529-008Burapren 0.75%Bupivacaine HydrochlorideIT3 Medical LLCANDACurrent
70529-008Burapren 0.75%Bupivacaine HydrochlorideIT3 Medical LLCANDACurrent
70859-041Point Of Care LM DEP 2Bupivacaine Hydrochloride,kenalog,Povidone-lodineNuCare Pharmaceuticals,Inc.ANDACurrent
70859-041Point Of Care LM DEP 2Bupivacaine Hydrochloride,kenalog,Povidone-lodineNuCare Pharmaceuticals,Inc.ANDACurrent
70859-042Point Of Care Kit KMBupivacaine Hydrochloride,kenalog,Povidone-lodineNuCare Pharmaceuticals,Inc.ANDACurrent
70859-042Point Of Care Kit KMBupivacaine Hydrochloride,kenalog,Povidone-lodineNuCare Pharmaceuticals,Inc.ANDACurrent
76420-008Bupivacaine HydrochlorideBupivacaine HydrochlorideAsclemed USA, Inc.ANDACurrent
76420-008Bupivacaine HydrochlorideBupivacaine HydrochlorideAsclemed USA, Inc.ANDACurrent
76420-018Bupivacaine HydrochlorideBupivacaine HydrochlorideAsclemed USA, Inc.ANDACurrent