FDA.reportPublic FDA data

Application 091113

Type
ANDA
Sponsor
ORCHID HLTHCARE

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
42043-320ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
42043-320ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
42043-320ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
42043-320ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
42043-321ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
42043-321ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
42043-321ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
42043-321ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
42043-322ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
42043-322ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
42043-322ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
42043-322ESZOPICLONEESZOPICLONEOrchidPharma IncANDACurrent
50436-0320ESZOPICLONEESZOPICLONEUnit Dose ServicesANDACurrent
50436-0322ESZOPICLONEESZOPICLONEUnit Dose ServicesANDACurrent
53217-149ESZOPICLONEESZOPICLONEAidarex Pharmaceuticals LLCANDACurrent
61919-323ESZOPICLONEESZOPICLONEDirectRXANDACurrent
61919-514ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
61919-514ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
61919-587ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
61919-587ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
63187-579ESZOPICLONEESZOPICLONEProficient Rx LPANDACurrent
63187-579ESZOPICLONEESZOPICLONEProficient Rx LPANDACurrent
63187-665ESZOPICLONEESZOPICLONEProficient Rx LPANDACurrent
63187-665ESZOPICLONEESZOPICLONEProficient Rx LPANDACurrent
68788-8953ESZOPICLONEESZOPICLONEPreferred Pharmaceuticals Inc.ANDACurrent
68788-9315ESZOPICLONEESZOPICLONEPreferred Pharmaceuticals, Inc.ANDACurrent
69452-347ESZOPICLONEESZOPICLONEBionpharma Inc.ANDACurrent
69452-348ESZOPICLONEESZOPICLONEBionpharma Inc.ANDACurrent
69452-349ESZOPICLONEESZOPICLONEBionpharma Inc.ANDACurrent
71335-0005ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
71335-0005ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
71335-0005ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
71335-0005ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
71335-0148ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
71335-0148ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
71335-0148ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
71335-0148ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
71335-1794ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
71335-1794ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
71335-1794ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent