FDA.report

Application 078462

Type
ANDA
Sponsor
AUROBINDO PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001TOPIRAMATETOPIRAMATETABLET;ORAL25MGNoNo
002TOPIRAMATETOPIRAMATETABLET;ORAL50MGNoNo
003TOPIRAMATETOPIRAMATETABLET;ORAL100MGNoNo
004TOPIRAMATETOPIRAMATETABLET;ORAL200MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-705TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-705TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-705TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-705TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-706TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-706TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-706TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-706TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-707TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-707TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-707TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-707TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-708TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-708TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-708TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
16571-708TopiramateTopiramateRising Pharma Holdings, Inc.ANDACurrent
57237-134TopiramateTopiramateCitron Pharma LLCANDACurrent
57237-135TopiramateTopiramateCitron Pharma LLCANDACurrent
57237-136TopiramateTopiramateCitron Pharma LLCANDACurrent
57237-137TopiramateTopiramateCitron Pharma LLCANDACurrent
65862-171TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-171TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-171TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-171TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-171TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-171TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-171TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-172TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-172TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-172TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-172TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-172TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-172TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-172TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-173TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-173TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-173TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-173TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-173TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-173TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-173TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-174TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-174TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-174TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-174TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-174TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-174TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
65862-174TopiramateTopiramateAurobindo Pharma LimitedANDACurrent
70518-3460TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
80425-0202TopiramateTopiramateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents

DocumentSubmission typeDate
44386ORIG2009-04-14
9156ORIG2009-04-01
23909ORIG2008-02-01