FDA.reportPublic FDA data

Application 207092

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CASPOFUNGIN ACETATECASPOFUNGIN ACETATEPOWDER;INTRAVENOUS50MG/VIALNoNo
002CASPOFUNGIN ACETATECASPOFUNGIN ACETATEPOWDER;INTRAVENOUS70MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-613Caspofungin Acetatecaspofungin acetateAlvogen Inc.ANDACurrent
47781-613Caspofungin Acetatecaspofungin acetateAlvogen Inc.ANDACurrent
47781-613Caspofungin Acetatecaspofungin acetateAlvogen Inc.ANDACurrent
47781-614Caspofungin Acetatecaspofungin acetateAlvogen Inc.ANDACurrent
47781-614Caspofungin Acetatecaspofungin acetateAlvogen Inc.ANDACurrent
47781-614Caspofungin Acetatecaspofungin acetateAlvogen Inc.ANDACurrent
68083-158Caspofungin AcetateCaspofungin AcetateGland Pharma LimitedANDACurrent
68083-158Caspofungin AcetateCaspofungin AcetateGland Pharma LimitedANDACurrent
68083-158Caspofungin AcetateCaspofungin AcetateGland Pharma LimitedANDACurrent
68083-159Caspofungin AcetateCaspofungin AcetateGland Pharma LimitedANDACurrent
68083-159Caspofungin AcetateCaspofungin AcetateGland Pharma LimitedANDACurrent
68083-159Caspofungin AcetateCaspofungin AcetateGland Pharma LimitedANDACurrent
70860-106Caspofungin Acetatecaspofungin acetateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-106Caspofungin Acetatecaspofungin acetateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-106Caspofungin Acetatecaspofungin acetateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-107Caspofungin Acetatecaspofungin acetateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-107Caspofungin Acetatecaspofungin acetateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-107Caspofungin Acetatecaspofungin acetateAthenex Pharmaceutical Division, LLC.ANDACurrent
72266-106Caspofungin AcetateCaspofungin AcetateFosun Pharma USA Inc.ANDACurrent
72266-106Caspofungin AcetateCaspofungin AcetateFosun Pharma USA Inc.ANDACurrent
72266-106Caspofungin AcetateCaspofungin AcetateFosun Pharma USA Inc.ANDACurrent
72266-107Caspofungin AcetateCaspofungin AcetateFosun Pharma USA Inc.ANDACurrent
72266-107Caspofungin AcetateCaspofungin AcetateFosun Pharma USA Inc.ANDACurrent
72266-107Caspofungin AcetateCaspofungin AcetateFosun Pharma USA Inc.ANDACurrent
72611-700caspofungin acetatecaspofungin acetateAlmaject, Inc.ANDACurrent
72611-700caspofungin acetatecaspofungin acetateAlmaject, Inc.ANDACurrent
72611-700caspofungin acetatecaspofungin acetateAlmaject, Inc.ANDACurrent
72611-702Caspofungin Acetatecaspofungin acetateAlmaject, Inc.ANDACurrent
72611-702Caspofungin Acetatecaspofungin acetateAlmaject, Inc.ANDACurrent
72611-702Caspofungin Acetatecaspofungin acetateAlmaject, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49957ORIG2017-10-05