FDA.reportPublic FDA data

Application 078829

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZALEPLONZALEPLONCAPSULE;ORAL5MGNoNo
002ZALEPLONZALEPLONCAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-505ZALEPLONZALEPLONPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-505ZALEPLONZALEPLONPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-505ZALEPLONZALEPLONPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-505ZALEPLONZALEPLONPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-505ZALEPLONZALEPLONPD-Rx Pharmaceuticals, Inc.ANDACurrent
57237-239ZALEPLONZALEPLONRising Health, LLCANDACurrent
57237-239ZALEPLONZALEPLONRising Health, LLCANDACurrent
57237-240ZALEPLONZALEPLONRising Health, LLCANDACurrent
57237-240ZALEPLONZALEPLONRising Health, LLCANDACurrent
65862-214ZALEPLONZALEPLONAurobindo Pharma LimitedANDACurrent
65862-214ZALEPLONZALEPLONAurobindo Pharma LimitedANDACurrent
65862-214ZALEPLONZALEPLONAurobindo Pharma LimitedANDACurrent
65862-215ZALEPLONZALEPLONAurobindo Pharma LimitedANDACurrent
65862-215ZALEPLONZALEPLONAurobindo Pharma LimitedANDACurrent
65862-215ZALEPLONZALEPLONAurobindo Pharma LimitedANDACurrent
71335-1054ZALEPLONZALEPLONBryant Ranch PrepackANDACurrent
71335-1054ZALEPLONZALEPLONBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23922ORIG2008-07-01
9188ORIG2008-06-10