Application 077627

Type
ANDA
Sponsor
GLENMARK GENERICS

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 42.

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
A077627-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A077627-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A077627-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A077627-004TOPIRAMATETOPIRAMATE200MGTABLET / 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
A077627-001AB
A077627-002AB
A077627-003AB
A077627-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077627-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077627-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077627-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077627-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077627-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077627-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077627-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077627-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077627-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077627-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077627-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077627-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077627-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077627-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077627-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077627-004TOPIRAMATE200MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077627-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077627-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077627-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077627-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077627-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077627-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077627-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077627-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077627-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077627-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077627-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077627-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077627-001TOPIRAMATE25MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077627-002TOPIRAMATE50MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077627-003TOPIRAMATE100MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077627-004TOPIRAMATE200MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077627-001TOPIRAMATE25MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077627-002TOPIRAMATE50MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077627-003TOPIRAMATE100MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077627-004TOPIRAMATE200MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077627-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077627-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077627-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077627-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077627-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077627-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077627-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077627-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077627-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077627-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077627-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077627-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077627-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077627-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077627-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077627-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077627-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077627-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077627-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077627-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077627-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077627-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077627-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077627-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077627-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077627-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077627-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077627-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077627-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077627-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077627-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077627-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077627-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077627-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077627-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077627-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077627-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077627-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077627-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077627-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077627-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077627-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077627-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077627-004AB1d8e5a09893c0…

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 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEREMEDYREPACK INC.610d4df7-703f-4070-9adc-3e57ca05a2f12026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
ndc (product): 70518-2955
TopiramateTOPIRAMATEUnit Dose Solutions, Inc.562f3fec-489b-4662-e063-6294a90a4ea22026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
TopiramateTOPIRAMATEGlenmark Pharmaceuticals Inc., USA35312f49-decf-428d-bf5f-4215b762ed3c2026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
ndc (product): 68462-109
ndc (product): 68462-108
ndc (product): 68462-110
ndc (product): 68462-153
TopiramateTOPIRAMATENorthwind Health Company, LLCae63e0e2-ceb1-4cc7-88fa-92cfa45169602026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
ndc (product): 51655-608
TopiramateTOPIRAMATEREMEDYREPACK INC.3f99b26b-79b9-4efb-aa2c-2868e1e126c82025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
TopiramateTOPIRAMATEProficient Rx LPa712d050-d5de-4685-a80a-548ab080fdb72021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
ndc (product): 63187-118
TopiramateTOPIRAMATEProficient Rx LP5d9b2c1d-565e-4c43-96ef-e5cd2593d0a82020-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
ndc (product): 63187-283
ndc (product): 63187-479

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 82 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8138TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8138TopiramateTopiramateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8138TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8139TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8139TopiramateTopiramateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8139TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8140TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8140TopiramateTopiramateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8140TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-489TopiramateTopiramateBlenheim Pharmacal, Inc.ANDACurrent
10544-847TopiramateTopiramateBlenheim Pharmacal, Inc.ANDACurrent
33261-106TopiramateTopiramateAidarex Pharmaceuticals LLCANDACurrent
43063-573TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-573TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-573TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-573TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-573TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-605TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-605TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-605TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-605TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-605TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-612TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-612TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-612TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-612TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-612TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
51655-032TOPIRAMATETOPIRAMATENorthwind Pharmaceuticals, LLCANDACurrent
51655-608TOPIRAMATETOPIRAMATENorthwind Pharmaceuticals, LLCANDACurrent
51655-609TopiramateTopiramateNorthwind Pharmaceuticals, LLCANDACurrent
63187-118TopiramateTopiramateProficient Rx LPANDACurrent
63187-118TopiramateTopiramateProficient Rx LPANDACurrent
63187-283TopiramateTopiramateProficient Rx LPANDACurrent
63187-283TopiramateTopiramateProficient Rx LPANDACurrent
63187-479TopiramateTopiramateProficient Rx LPANDACurrent
63187-479TopiramateTopiramateProficient Rx LPANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-6366TopiramateTopiramatePreferred PharmaceuticalcANDACurrent
68788-8967TopiramateTopiramatePreferred PharmaceuticalsANDACurrent
70518-2899TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
70518-2899TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
70518-2955TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
70518-2955TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
70518-3067TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
70518-3067TopiramateTopiramateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23878ORIG2009-04-14