FDA.reportPublic FDA data

Application 202929

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

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
33342-299EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-299EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-299EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-299EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-299EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-300EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-300EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-300EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-300EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-300EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-301EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-301EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-301EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-301EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
33342-301EszopicloneEszopicloneMacleods Pharmaceuticals LimitedANDACurrent
50436-0299EszopicloneEszopicloneUnit Dose ServicesANDACurrent
50436-0300EszopicloneEszopicloneUnit Dose ServicesANDACurrent
50436-0301EszopicloneEszopicloneUnit Dose ServicesANDACurrent
53217-151EszopicloneEszopicloneAidarex Pharmaceuticals LLCANDACurrent
55700-581EszopicloneEszopicloneQuality Care Products LLCANDACurrent
55700-581EszopicloneEszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-581EszopicloneEszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-581EszopicloneEszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-610EszopicloneEszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-610EszopicloneEszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-610EszopicloneEszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-621EszopicloneEszopicloneLake Erie Medical DBA QuaANDACurrent
55700-621EszopicloneEszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-621EszopicloneEszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-621EszopicloneEszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-621EszopicloneEszopicloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-325EszopicloneEszopicloneSt. Mary's Medical Park PharmacyANDACurrent
60760-511EszopicloneEszopicloneSt. Mary's Medical Park PharmacyANDACurrent
60760-511EszopicloneEszopicloneSt. Mary's Medical Park PharmacyANDACurrent
61919-033ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
61919-033ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
61919-033ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
61919-119ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
61919-119ESZOPICLONEESZOPICLONEDirect_RxANDACurrent
61919-119ESZOPICLONEESZOPICLONEDirect_RxANDACurrent
61919-119ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
61919-395ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
61919-395ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
61919-395ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
63187-817EszopicloneEszopicloneProficient Rx LPANDACurrent
63187-817EszopicloneEszopicloneProficient Rx LPANDACurrent
63187-817EszopicloneEszopicloneProficient Rx LPANDACurrent
63187-843EszopicloneEszopicloneProficient Rx LPANDACurrent
63187-843EszopicloneEszopicloneProficient Rx LPANDACurrent
63187-843EszopicloneEszopicloneProficient Rx LPANDACurrent
63187-970EszopicloneEszopicloneProficient Rx LPANDACurrent
63187-970EszopicloneEszopicloneProficient Rx LPANDACurrent
63187-970EszopicloneEszopicloneProficient Rx LPANDACurrent
63187-970EszopicloneEszopicloneProficient Rx LPANDACurrent
68071-3376EszopicloneEszopicloneNuCarePharmaceuticals, InANDACurrent
68071-3376EszopicloneEszopicloneNuCarePharmaceuticals, Inc.ANDACurrent
68071-3376EszopicloneEszopicloneNuCarePharmaceuticals, Inc.ANDACurrent
68788-6953EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-6953EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-6953EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-6953EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7029EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7029EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7029EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7029EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7029EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7169EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7169EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7169EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7169EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7169EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
70518-3576EszopicloneEszopicloneREMEDYREPACK INC.ANDACurrent
71335-0089EszopicloneEszopicloneBryant Ranch PrepackANDACurrent
71335-0089EszopicloneEszopicloneBryant Ranch PrepackANDACurrent
71335-0116EszopicloneEszopicloneBryant Ranch PrepackANDACurrent
71335-0116EszopicloneEszopicloneBryant Ranch PrepackANDACurrent
71335-0598EszopicloneEszopicloneBryant Ranch PrepackANDACurrent
71335-0598EszopicloneEszopicloneBryant Ranch PrepackANDACurrent
76420-024EszopicloneEszopicloneAsclemed USA, Inc.ANDACurrent
76420-026EszopicloneEszopicloneAsclemed USA, Inc.ANDACurrent