FDA.reportPublic FDA data

Application 090318

Type
ANDA
Sponsor
MYLAN ASI

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-652Ropivacaine Hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-653Ropivacaine Hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
25021-671Ropivacaine Hydrochlorideropivacaine hydrochlorideSagent PharmaceuticalsANDACurrent
67457-875Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent
67457-875Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent
67457-875Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent
67457-876Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent
67457-876Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent
67457-876Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent
67457-877Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent
67457-877Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent
67457-877Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent
67457-878Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent
67457-878Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent
67457-878Ropivacaine Hydrochlorideropivacaine hydrochlorideMylan Institutional LLCANDACurrent