FDA.reportPublic FDA data

Application 091153

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESZOPICLONEESZOPICLONETABLET;ORAL1MGNoNo
002ESZOPICLONEESZOPICLONETABLET;ORAL2MGNoNo
003ESZOPICLONEESZOPICLONETABLET;ORAL3MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0290eszopicloneeszopicloneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0290eszopicloneeszopicloneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0290eszopicloneeszopicloneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0291eszopicloneeszopicloneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0291eszopicloneeszopicloneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0291eszopicloneeszopicloneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0292eszopicloneeszopicloneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0292eszopicloneeszopicloneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0292eszopicloneeszopicloneWest-Ward Pharmaceuticals Corp.ANDACurrent
55700-132eszopicloneeszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-133eszopicloneeszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-462ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
61919-462ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
63187-180eszopicloneeszopicloneProficient Rx LPANDACurrent
63187-330eszopicloneeszopicloneProficient Rx LPANDACurrent
63187-365eszopicloneeszopicloneProficient Rx LPANDACurrent
68071-2153eszopicloneeszopicloneNuCare Pharmaceuticals, Inc.ANDACurrent
68788-9238eszopicloneeszopiclonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9361eszopicloneeszopiclonePreferred Pharmaceuticals, Inc.ANDACurrent
71335-0784eszopicloneeszopicloneBryant Ranch PrepackANDACurrent
71335-0784eszopicloneeszopicloneBryant Ranch PrepackANDACurrent
71335-0784eszopicloneeszopicloneBryant Ranch PrepackANDACurrent