Application 078235

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

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 44.

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
A078235-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A078235-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A078235-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A078235-004TOPIRAMATETOPIRAMATE200MGTABLET / 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
A078235-001AB
A078235-002AB
A078235-003AB
A078235-004AB

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.

Product history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27c2088c7a36db…
2026-10-15 13:18:302026-09A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27c2088c7a36db…
2026-10-15 13:18:302026-09A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27c2088c7a36db…
2026-10-15 13:18:302026-09A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27c2088c7a36db…
2026-09-14 22:38:342026-08A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-272680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A078235-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A078235-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A078235-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A078235-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08A078235-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078235-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078235-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078235-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A078235-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078235-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078235-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078235-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078235-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078235-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-004AB12680178bc6a6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEAmerican Health Packaging1af94c80-2b17-409a-98f6-ce00f942351d2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
ndc (product): 68084-345
topiramateTOPIRAMATEMajor Pharmaceuticals6fb00bd8-c49e-46ef-9d6b-1b602e1d11d82025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEA-S Medication Solutions674c2c2e-014a-43a1-91a7-7214ffc4b1d72025-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
TopiramateTOPIRAMATEAdvanced Rx Pharmacy of Tennessee, LLCb353e7fb-b976-96d8-e053-2995a90a110a2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEZydus Lifesciences Limited57016639-89fe-43ad-89c4-5e7a756dddec2024-08-14Exact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATENuCare Pharmaceuticals,Inc.87dc077b-2c84-522b-e053-2995a90a68bc2024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEAdvanced Rx of Tennessee, LLC1a16d6a9-3dd1-ede8-e063-6294a90afe752024-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEA-S Medication Solutionsf7f2d1bc-9c65-4798-826f-6902b3ec81dc2023-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEProficient Rx LP80481455-7ad7-4f44-8113-b8b61d8581a02022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 193 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68084-345TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-345TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-345TopiramateTopiramateAmerican Health PackagingANDACurrent
68258-6040LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDispensing Solutions, Inc.ANDACurrent
68382-138topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-138topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-138topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-138topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-138topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-138topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-139topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-139topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-139topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-139topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-139topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-139topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-140topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-140topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-140topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-140topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-140topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-140topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-141topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-141topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-141topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-141topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-141topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-141topiramatetopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7351topiramatetopiramatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7351topiramatetopiramatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7351topiramatetopiramatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7351topiramatetopiramatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7460topiramatetopiramatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7460topiramatetopiramatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7460topiramatetopiramatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7460topiramatetopiramatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7468topiramatetopiramatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7468topiramatetopiramatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7468topiramatetopiramatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7568topiramatetopiramatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7568topiramatetopiramatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7568topiramatetopiramatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7568topiramatetopiramatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0233topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-0233topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-0233topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-0233topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1180topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1180topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1180topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1180topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1180topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1718topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1718topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1718topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1718topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1718topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1718topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1718topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1937topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1937topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1937topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1937topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1937topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1937topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1937topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1937topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1953topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1953topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1953topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1953topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1953topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1953topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2001topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2001topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2001topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2001topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2001topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2001topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2001topiramatetopiramateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44379ORIG2009-04-14