FDA.reportPublic FDA data

Application 205612

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION40MG/20ML (2MG/ML)NoNo
002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION200MG/100ML (2MG/ML)NoNo
003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION100MG/20ML (5MG/ML)NoNo
004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION150MG/30ML (5MG/ML)NoNo
005ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION150MG/20ML (7.5MG/ML)NoNo
006ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION100MG/10ML (10MG/ML)NoNo
007ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION200MG/20ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-195Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-195Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-195Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-196Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-196Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-196Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-197Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-197Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-197Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-198Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-198Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-198Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-199Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-199Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-199Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-200Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-200Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-200Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-201Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-201Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-201Ropivacaine HydrochlorideRopivacaine HydrochlorideAuroMedics Pharma LLCANDACurrent
70518-2681Ropivacaine HydrochlorideRopivacaine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2681Ropivacaine HydrochlorideRopivacaine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2681Ropivacaine HydrochlorideRopivacaine HydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40485ORIG2016-07-18
10476ORIG2016-07-15