Application 090278

Type
ANDA
Sponsor
SUN PHARM

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
A090278-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A090278-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A090278-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A090278-004TOPIRAMATETOPIRAMATE200MGTABLET / ORAL2009-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090278-001AB
A090278-002AB
A090278-003AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-004TOPIRAMATE200MGTABLET / ORAL2009-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-004TOPIRAMATE200MGTABLET / ORAL2009-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-004TOPIRAMATE200MGTABLET / ORAL2009-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090278-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090278-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090278-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-003AB179d66fd596c7…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.e846124d-e9e6-42c7-83f1-5df170d3f70b2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepack47ef2964-3a41-4bfd-86fb-d44560b9961f2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepack484c132f-3d3d-4218-b22f-82e9b56cc2f42026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.1b847969-2124-4350-94b0-ef5ba707673b2026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
ndc (product): 43063-997
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.021005ab-6a00-40d8-9aee-20c91613b4d52026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
ndc (product): 43063-998
TopiramateTOPIRAMATESun Pharmaceutical Industries, Inc.3c909a53-ae66-4b28-a741-b60bb25a69cf2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
ndc (product): 47335-711
ndc (product): 47335-707
ndc (product): 47335-710
ndc (product): 47335-712
TopiramateTOPIRAMATEBryant Ranch Prepack61390be3-7553-4cb5-b5da-7571ed7d4b172024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepackffaacad8-4594-45a8-b292-02a84cd0c35b2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATENuCare Pharmaceuticals,Inc.9ddb8451-a455-87ec-e053-2995a90a5e5e2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEProficient Rx LP8bd03bb2-3b9b-4707-a9a4-5618ddc3832f2023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TOPIRAMATETOPIRAMATEProficient Rx LPa30c583a-4b0a-43a6-ae76-19b1a5e916ca2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEProficient Rx LPe382a731-ef73-4990-bc74-ffc3a91ff3ba2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEProficient Rx LP7d6752ce-7a56-4b04-ab15-cbd40aa5cc942019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATESun Pharmaceutical Industries, Inc.2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef2018-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 185 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-083TopiramateTopiramateApotheca Inc.ANDACurrent
12634-452TopiramateTopiramateApotheca Inc.ANDACurrent
12634-453TopiramateTopiramateApotheca Inc.ANDACurrent
21695-162TOPIRAMATETOPIRAMATERebel Distributors CorpANDACurrent
21695-205TOPIRAMATETOPIRAMATERebel Distributors CorpANDACurrent
21695-348TOPIRAMATETOPIRAMATERebel Distributors CorpANDACurrent
21695-349TOPIRAMATETOPIRAMATERebel Distributors CorpANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-998TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-998TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-998TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-998TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-551TopiramateTopiramatemedsource pharmaceuticalsANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
50090-3752TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3752TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3752TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3931TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3931TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3931TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3932TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3932TopiramateTopiramateA-S Medication SolutionsANDACurrent
50436-9952TopiramateTopiramateUnit Dose ServicesANDACurrent
52959-643TOPIRAMATETOPIRAMATEH.J. Harkins Company, Inc.ANDACurrent
53808-0967TOPIRAMATETOPIRAMATEState of Florida DOH Central PharmacyANDACurrent
55700-596TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-596TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-596TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-691TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-691TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-691TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-894TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-894TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-894TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-894TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-894TopiramateTopiramateQuality Care Products, LLCANDACurrent
61919-439TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-439TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-439TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-439TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-439TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-817TOPIRAMATETOPIRAMATEDIRECT RXANDACurrent
61919-817TOPIRAMATETOPIRAMATEDIRECT RXANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23940ORIG2009-04-14