FDA.reportPublic FDA data

Application 210594

Type
ANDA
Sponsor
NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/VIALNoNo
002REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2MG BASE/VIALNoNo
003REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDEINJECTABLE;INJECTIONEQ 5MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9391REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9391REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9392REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9392REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9393REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9393REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ANDACurrent
68475-505REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDENavinta LLCANDACurrent
68475-506REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDENavinta LLCANDACurrent
68475-507REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDENavinta LLCANDACurrent