FDA.reportPublic FDA data

Application 091151

Type
ANDA
Sponsor
MYLAN PHARMS INC

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
0378-5270EszopicloneeszopicloneMylan Pharmaceuticals Inc.ANDACurrent
0378-5270EszopicloneeszopicloneMylan Pharmaceuticals Inc.ANDACurrent
0378-5270EszopicloneeszopicloneMylan Pharmaceuticals Inc.ANDACurrent
0378-5271EszopicloneeszopicloneMylan Pharmaceuticals Inc.ANDACurrent
0378-5271EszopicloneeszopicloneMylan Pharmaceuticals Inc.ANDACurrent
0378-5271EszopicloneeszopicloneMylan Pharmaceuticals Inc.ANDACurrent
0378-5272EszopicloneeszopicloneMylan Pharmaceuticals Inc.ANDACurrent
0378-5272EszopicloneeszopicloneMylan Pharmaceuticals Inc.ANDACurrent
0378-5272EszopicloneeszopicloneMylan Pharmaceuticals Inc.ANDACurrent
43353-185EszopicloneeszopicloneAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-185EszopicloneeszopicloneAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-200EszopicloneeszopicloneAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-200EszopicloneeszopicloneAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2606EszopicloneeszopicloneA-S Medication SolutionsANDACurrent
51079-349EszopicloneeszopicloneMylan Institutional Inc.ANDACurrent
51079-349EszopicloneeszopicloneMylan Institutional Inc.ANDACurrent
51079-414EszopicloneeszopicloneMylan Institutional Inc.ANDACurrent
51079-414EszopicloneeszopicloneMylan Institutional Inc.ANDACurrent
60429-632EszopicloneeszopicloneGolden State Medical Supply, Inc.ANDACurrent
60429-632EszopicloneeszopicloneGolden State Medical Supply, Inc.ANDACurrent
60429-632EszopicloneeszopicloneGolden State Medical Supply, Inc.ANDACurrent
60429-632EszopicloneeszopicloneGolden State Medical Supply, Inc.ANDACurrent
60429-633EszopicloneeszopicloneGolden State Medical Supply, Inc.ANDACurrent
60429-633EszopicloneEszopicloneGolden State Medical Supply, Inc.ANDACurrent
60429-633EszopicloneEszopicloneGolden State Medical Supply, Inc.ANDACurrent
60429-633EszopicloneEszopicloneGolden State Medical Supply, Inc.ANDACurrent
60429-634EszopicloneeszopicloneGolden State Medical Supply, Inc.ANDACurrent
60429-634EszopicloneeszopicloneGolden State Medical Supply, Inc.ANDACurrent
60429-634EszopicloneeszopicloneGolden State Medical Supply, Inc.ANDACurrent
60429-634EszopicloneeszopicloneGolden State Medical Supply, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43245ORIG2013-04-10