FDA.reportPublic FDA data

Application 206166

Type
ANDA
Sponsor
INFORLIFE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION200MG/100ML (2MG/ML)NoNo
002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION400MG/200ML (2MG/ML)NoNo
003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION500MG/100ML (5MG/ML)NoNo
004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION1GM/200ML (5MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-652ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-652ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-652ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-652ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-652ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-652ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-671ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-671ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-671ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-671ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-671ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-671ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-671ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-671ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-671ropivacaine hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54894ORIG2018-07-16