FDA.reportPublic FDA data

Application 077492

Type
ANDA
Sponsor
OHM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALSARTANVALSARTANTABLET;ORAL40MGNoNo
002VALSARTANVALSARTANTABLET;ORAL80MGNoNo
003VALSARTANVALSARTANTABLET;ORAL160MGNoNo
004VALSARTANVALSARTANTABLET;ORAL320MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-203VALSARTANVALSARTANAphena Pharma Solutions - Tennessee, LLCANDACurrent
51655-652VALSARTANVALSARTANNorthwind Pharmaceuticals, LLCANDACurrent
51655-751ValsartanValsartanNorthwind PharmaceuticalsANDACurrent
51660-140VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-140VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-140VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-140VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-140VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-141VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-141VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-141VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-141VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-141VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-142VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-142VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-142VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-142VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-142VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-143VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-143VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-143VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-143VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent
51660-143VALSARTANVALSARTANOhm Laboratories Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18465ORIG2014-07-31
31249ORIG2014-06-27
9053ORIG2012-09-21