FDA.reportPublic FDA data

Application 078462

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPIRAMATETOPIRAMATETABLET;ORAL25MGNoNo
002TOPIRAMATETOPIRAMATETABLET;ORAL50MGNoNo
003TOPIRAMATETOPIRAMATETABLET;ORAL100MGNoNo
004TOPIRAMATETOPIRAMATETABLET;ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078462-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A078462-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A078462-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A078462-004TOPIRAMATETOPIRAMATE200MGTABLET / ORALAB2009-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A078462-001AB
A078462-002AB
A078462-003AB
A078462-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078462-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A078462-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A078462-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A078462-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078462-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078462-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078462-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078462-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.4833f2e8-16b7-406f-937a-55bc978bf92c2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078462
application number: ANDA078462
TopiramateTOPIRAMATEAurobindo Pharma Limited32b48ea0-a215-43b8-83b4-a5435a686d682026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078462
application number: ANDA078462
ndc (product): 65862-172
ndc (product): 65862-174
ndc (product): 65862-173
ndc (product): 65862-171
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.5424d59e-74f1-4c3c-b737-79e9776e0b602026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078462
application number: ANDA078462
TopiramateTOPIRAMATENCS HealthCare of KY, LLC dba Vangard Labs444464fb-6a95-4e10-99a7-fdbc7dbb4c482025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078462
application number: ANDA078462

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
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#

Document, Submission type, Date table
DocumentSubmission typeDate
44386ORIG2009-04-14
9156ORIG2009-04-01
23909ORIG2008-02-01