FDA.reportPublic FDA data

Application 210102

Type
ANDA
Sponsor
GLAND PHARMA LTD

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68083-262Ropivacaine hydrochlorideRopivacaine hydrochlorideGland Pharma LimitedANDACurrent
68083-263Ropivacaine hydrochlorideRopivacaine hydrochlorideGland Pharma LimitedANDACurrent