FDA.reportPublic FDA data

Application 201635

Type
NDA
Sponsor
SUPERNUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TROKENDI XRTOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL25MGYesNo
002TROKENDI XRTOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL50MGYesNo
003TROKENDI XRTOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL100MGYesNo
004TROKENDI XRTOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL200MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N201635-001TROKENDI XRTOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16
N201635-002TROKENDI XRTOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16
N201635-003TROKENDI XRTOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16
N201635-004TROKENDI XRTOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD, RS2013-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N201635-001AB1
N201635-002AB1
N201635-003AB1
N201635-004AB1

Orange Book patents#

Current patent rows page 1 of 1 · 80 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N201635-001103147902027-11-16U-1675Drug product2019-07-09
N201635-001103147902027-11-16U-1992Drug product2019-07-09
N201635-00182985802027-11-16U-106Drug product2013-08-22
N201635-00182985802027-11-16U-1992Drug product2013-08-22
N201635-00186636832027-11-16U-106Drug product
N201635-00186636832027-11-16U-1992Drug product
N201635-00188772482027-11-16U-106Drug product2014-11-12
N201635-00188772482027-11-16U-1992Drug product2014-11-12
N201635-00188891912027-11-16U-1062014-12-17
N201635-00188891912027-11-16U-19922014-12-17
N201635-00189929892027-11-16U-1675Drug product2015-04-08
N201635-00189929892027-11-16U-1992Drug product2015-04-08
N201635-00195499402027-11-16U-1675Drug product2017-01-27
N201635-00195499402027-11-16U-1992Drug product2017-01-27
N201635-00195550042027-11-16U-1675Drug product2017-02-09
N201635-00195550042027-11-16U-1992Drug product2017-02-09
N201635-00196229832027-11-16U-1675Drug product2017-04-20
N201635-00196229832027-11-16U-1992Drug product2017-04-20
N201635-00182985762028-04-04U-106Drug product2013-08-22
N201635-00182985762028-04-04U-1992Drug product2013-08-22
N201635-002103147902027-11-16U-1675Drug product2019-07-09
N201635-002103147902027-11-16U-1992Drug product2019-07-09
N201635-00282985802027-11-16U-106Drug product2013-08-22
N201635-00282985802027-11-16U-1992Drug product2013-08-22
N201635-00286636832027-11-16U-106Drug product
N201635-00286636832027-11-16U-1992Drug product
N201635-00288772482027-11-16U-106Drug product2014-11-12
N201635-00288772482027-11-16U-1992Drug product2014-11-12
N201635-00288891912027-11-16U-1062014-12-17
N201635-00288891912027-11-16U-19922014-12-17
N201635-00289929892027-11-16U-1675Drug product2015-04-08
N201635-00289929892027-11-16U-1992Drug product2015-04-08
N201635-00295499402027-11-16U-1675Drug product2017-01-27
N201635-00295499402027-11-16U-1992Drug product2017-01-27
N201635-00295550042027-11-16U-1675Drug product2017-02-09
N201635-00295550042027-11-16U-1992Drug product2017-02-09
N201635-00296229832027-11-16U-1675Drug product2017-04-20
N201635-00296229832027-11-16U-1992Drug product2017-04-20
N201635-00282985762028-04-04U-106Drug product2013-08-22
N201635-00282985762028-04-04U-1992Drug product2013-08-22
N201635-003103147902027-11-16U-1675Drug product2019-07-09
N201635-003103147902027-11-16U-1992Drug product2019-07-09
N201635-00382985802027-11-16U-106Drug product2013-08-22
N201635-00382985802027-11-16U-1992Drug product2013-08-22
N201635-00386636832027-11-16U-106Drug product
N201635-00386636832027-11-16U-1992Drug product
N201635-00388772482027-11-16U-106Drug product2014-11-12
N201635-00388772482027-11-16U-1992Drug product2014-11-12
N201635-00388891912027-11-16U-1062014-12-17
N201635-00388891912027-11-16U-19922014-12-17
N201635-00389929892027-11-16U-1675Drug product2015-04-08
N201635-00389929892027-11-16U-1992Drug product2015-04-08
N201635-00395499402027-11-16U-1675Drug product2017-01-27
N201635-00395499402027-11-16U-1992Drug product2017-01-27
N201635-00395550042027-11-16U-1675Drug product2017-02-09
N201635-00395550042027-11-16U-1992Drug product2017-02-09
N201635-00396229832027-11-16U-1675Drug product2017-04-20
N201635-00396229832027-11-16U-1992Drug product2017-04-20
N201635-00382985762028-04-04U-106Drug product2013-08-22
N201635-00382985762028-04-04U-1992Drug product2013-08-22
N201635-004103147902027-11-16U-1675Drug product2019-07-09
N201635-004103147902027-11-16U-1992Drug product2019-07-09
N201635-00482985802027-11-16U-106Drug product2013-08-22
N201635-00482985802027-11-16U-1992Drug product2013-08-22
N201635-00486636832027-11-16U-106Drug product
N201635-00486636832027-11-16U-1992Drug product
N201635-00488772482027-11-16U-106Drug product2014-11-12
N201635-00488772482027-11-16U-1992Drug product2014-11-12
N201635-00488891912027-11-16U-1062014-12-17
N201635-00488891912027-11-16U-19922014-12-17
N201635-00489929892027-11-16U-1675Drug product2015-04-08
N201635-00489929892027-11-16U-1992Drug product2015-04-08
N201635-00495499402027-11-16U-1675Drug product2017-01-27
N201635-00495499402027-11-16U-1992Drug product2017-01-27
N201635-00495550042027-11-16U-1675Drug product2017-02-09
N201635-00495550042027-11-16U-1992Drug product2017-02-09
N201635-00496229832027-11-16U-1675Drug product2017-04-20
N201635-00496229832027-11-16U-1992Drug product2017-04-20
N201635-00482985762028-04-04U-106Drug product2013-08-22
N201635-00482985762028-04-04U-1992Drug product2013-08-22

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N201635-001TROKENDI XR25MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-1684e616aacf4f…
2026-09-14 22:38:342026-08N201635-002TROKENDI XR50MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-1684e616aacf4f…
2026-09-14 22:38:342026-08N201635-003TROKENDI XR100MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-1684e616aacf4f…
2026-09-14 22:38:342026-08N201635-004TROKENDI XR200MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD, RS2013-08-1684e616aacf4f…
2026-08-18 06:07:402026-07N201635-001TROKENDI XR25MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16caaa826d4ba7…
2026-08-18 06:07:402026-07N201635-002TROKENDI XR50MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16caaa826d4ba7…
2026-08-18 06:07:402026-07N201635-003TROKENDI XR100MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16caaa826d4ba7…
2026-08-18 06:07:402026-07N201635-004TROKENDI XR200MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD, RS2013-08-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N201635-001TROKENDI XR25MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201635-002TROKENDI XR50MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201635-003TROKENDI XR100MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201635-004TROKENDI XR200MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD, RS2013-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201635-001TROKENDI XR25MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201635-002TROKENDI XR50MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201635-003TROKENDI XR100MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201635-004TROKENDI XR200MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD, RS2013-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N201635-001TROKENDI XR25MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201635-002TROKENDI XR50MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201635-003TROKENDI XR100MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201635-004TROKENDI XR200MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD, RS2013-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201635-001TROKENDI XR25MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201635-002TROKENDI XR50MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201635-003TROKENDI XR100MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201635-004TROKENDI XR200MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD, RS2013-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201635-001TROKENDI XR25MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201635-002TROKENDI XR50MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201635-003TROKENDI XR100MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201635-004TROKENDI XR200MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD, RS2013-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201635-001TROKENDI XR25MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201635-002TROKENDI XR50MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201635-003TROKENDI XR100MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201635-004TROKENDI XR200MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD, RS2013-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201635-001TROKENDI XR25MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201635-002TROKENDI XR50MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201635-003TROKENDI XR100MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201635-004TROKENDI XR200MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD, RS2013-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201635-001TROKENDI XR25MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201635-002TROKENDI XR50MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201635-003TROKENDI XR100MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD2013-08-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201635-004TROKENDI XR200MGCAPSULE, EXTENDED RELEASE / ORALAB1RLD, RS2013-08-165bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N201635-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08N201635-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08N201635-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08N201635-004AB1184e616aacf4f…
2026-08-18 06:07:402026-07N201635-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N201635-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N201635-003AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N201635-004AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N201635-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201635-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201635-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201635-004AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201635-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201635-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201635-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201635-004AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N201635-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201635-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201635-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201635-004AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201635-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201635-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201635-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201635-004AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201635-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201635-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201635-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201635-004AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201635-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201635-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201635-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201635-004AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201635-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201635-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201635-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201635-004AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201635-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201635-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201635-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201635-004AB115bbf6a4d5a75…

Observed Orange Book patent history#

Patent history page 1 of 86 · 3,440 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N201635-001103147902027-11-16U-1675Drug product2019-07-0984e616aacf4f…
2026-09-14 22:38:342026-08N201635-001103147902027-11-16U-1992Drug product2019-07-0984e616aacf4f…
2026-09-14 22:38:342026-08N201635-00182985802027-11-16U-1992Drug product2013-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N201635-00182985802027-11-16U-106Drug product2013-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N201635-00186636832027-11-16U-1992Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N201635-00186636832027-11-16U-106Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N201635-00188772482027-11-16U-1992Drug product2014-11-1284e616aacf4f…
2026-09-14 22:38:342026-08N201635-00188772482027-11-16U-106Drug product2014-11-1284e616aacf4f…
2026-09-14 22:38:342026-08N201635-00188891912027-11-16U-1062014-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N201635-00188891912027-11-16U-19922014-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N201635-00189929892027-11-16U-1675Drug product2015-04-0884e616aacf4f…
2026-09-14 22:38:342026-08N201635-00189929892027-11-16U-1992Drug product2015-04-0884e616aacf4f…
2026-09-14 22:38:342026-08N201635-00195499402027-11-16U-1992Drug product2017-01-2784e616aacf4f…
2026-09-14 22:38:342026-08N201635-00195499402027-11-16U-1675Drug product2017-01-2784e616aacf4f…
2026-09-14 22:38:342026-08N201635-00195550042027-11-16U-1992Drug product2017-02-0984e616aacf4f…
2026-09-14 22:38:342026-08N201635-00195550042027-11-16U-1675Drug product2017-02-0984e616aacf4f…
2026-09-14 22:38:342026-08N201635-00196229832027-11-16U-1992Drug product2017-04-2084e616aacf4f…
2026-09-14 22:38:342026-08N201635-00196229832027-11-16U-1675Drug product2017-04-2084e616aacf4f…
2026-09-14 22:38:342026-08N201635-00182985762028-04-04U-106Drug product2013-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N201635-00182985762028-04-04U-1992Drug product2013-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N201635-002103147902027-11-16U-1992Drug product2019-07-0984e616aacf4f…
2026-09-14 22:38:342026-08N201635-002103147902027-11-16U-1675Drug product2019-07-0984e616aacf4f…
2026-09-14 22:38:342026-08N201635-00282985802027-11-16U-106Drug product2013-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N201635-00282985802027-11-16U-1992Drug product2013-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N201635-00286636832027-11-16U-106Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N201635-00286636832027-11-16U-1992Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N201635-00288772482027-11-16U-1992Drug product2014-11-1284e616aacf4f…
2026-09-14 22:38:342026-08N201635-00288772482027-11-16U-106Drug product2014-11-1284e616aacf4f…
2026-09-14 22:38:342026-08N201635-00288891912027-11-16U-1062014-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N201635-00288891912027-11-16U-19922014-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N201635-00289929892027-11-16U-1675Drug product2015-04-0884e616aacf4f…
2026-09-14 22:38:342026-08N201635-00289929892027-11-16U-1992Drug product2015-04-0884e616aacf4f…
2026-09-14 22:38:342026-08N201635-00295499402027-11-16U-1992Drug product2017-01-2784e616aacf4f…
2026-09-14 22:38:342026-08N201635-00295499402027-11-16U-1675Drug product2017-01-2784e616aacf4f…
2026-09-14 22:38:342026-08N201635-00295550042027-11-16U-1992Drug product2017-02-0984e616aacf4f…
2026-09-14 22:38:342026-08N201635-00295550042027-11-16U-1675Drug product2017-02-0984e616aacf4f…
2026-09-14 22:38:342026-08N201635-00296229832027-11-16U-1992Drug product2017-04-2084e616aacf4f…
2026-09-14 22:38:342026-08N201635-00296229832027-11-16U-1675Drug product2017-04-2084e616aacf4f…
2026-09-14 22:38:342026-08N201635-00282985762028-04-04U-1992Drug product2013-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N201635-00282985762028-04-04U-106Drug product2013-08-2284e616aacf4f…

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 3 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topiramateTOPIRAMATEREMEDYREPACK INC.2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db2026-05-19Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEUpsher-Smith Laboratories, LLC691d276c-9cc1-4d39-828f-0f44d7ef63282026-05-15Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEVitruvias Therapeutics, Inc.a9d7c5ef-daf9-4f97-8673-7f4a2007f4082026-05-07Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TOPIRAMATETOPIRAMATEGlenmark Pharmaceuticals Inc., USA54bfabce-1f8a-40ee-8b55-efce8fe6fbf12026-04-30Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEREMEDYREPACK INC.149d20de-f262-4567-aa97-d4d28a1653cb2026-04-30Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATECoupler LLC50b10a3d-883c-8891-e063-6394a90a86a12026-04-30Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEGlenmark Pharmaceuticals Inc., USA872927eb-0b61-44bb-9892-3c700b6f21812026-04-29Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEQuallent Pharmaceuticals Health LLC9dae6824-6913-42de-b98a-cdcb0d3b4a462026-04-25Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.e4886adf-199d-4b19-a4ef-75f8f94cb54e2026-04-22Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEAjanta Pharma USA Inc.b94629e3-ae2e-473e-b2f5-06e32ee19aa92026-04-20Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.a5ca2fce-bd2d-40db-b963-e3ec27c8bf232026-04-16Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.67dcdd6e-48bc-418e-a887-805929d83ce02026-04-15Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEGlenmark Pharmaceuticals Inc., USA35312f49-decf-428d-bf5f-4215b762ed3c2026-04-10Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEUnichem Pharmaceuticals (USA), Inc.6ee00e82-799d-445e-b658-a9712c49a28e2026-04-06Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEAdvagen Pharma Ltd48169bbc-4fb2-4bc4-9bdd-de71bf7722df2026-04-03Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATETeva Pharmaceuticals, Inc.4f20155f-05b9-40ec-af34-3b58aa8d60d42026-04-01Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.f72774dd-c7eb-41f9-9837-02baf77cc5232026-03-30Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATELupin Pharmaceuticals, Inc.e310afcd-1260-434e-a994-34549c789d992026-03-30Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEAurobindo Pharma Limited32b48ea0-a215-43b8-83b4-a5435a686d682026-03-24Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TOPIRAMATETOPIRAMATEAurobindo Pharma Limitedd1588c37-9da9-4ccb-b78a-64234938a1152026-03-24Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE

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 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17772-101Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-101Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-101Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-101Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-101Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-101Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-101Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-101Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-101Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-102Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-102Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-102Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-102Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-102Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-102Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-102Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-102Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-102Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-103Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-103Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-103Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-103Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-103Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-103Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-103Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-103Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-103Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-104Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-104Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-104Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-104Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-104Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-104Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-104Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-104Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent
17772-104Trokendi XRtopiramateSupernus PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85337SUPPL 2026-03-12
85300SUPPL 2026-03-09
85353SUPPL 2026-03-06
82130SUPPL 2025-05-01
82129SUPPL 2025-05-01
81538SUPPL 2025-03-12
81534SUPPL 2025-03-11
77201SUPPL 2024-01-10
77190SUPPL 2024-01-05
72307SUPPL2022-10-11
72306SUPPL2022-10-11
72284SUPPL2022-10-11
70100SUPPL2022-02-07
70099SUPPL2022-02-07
70073SUPPL2022-02-04
65294SUPPL2020-11-19
65279SUPPL2020-11-19
65278SUPPL2020-11-19
57792SUPPL2019-02-22
57774SUPPL2019-02-22
50973SUPPL2018-01-09
50972SUPPL2018-01-04
47955SUPPL2017-04-12
47903SUPPL2017-04-07
47902SUPPL2017-04-07
47901SUPPL2017-04-07
45099SUPPL2016-08-22
45227SUPPL2016-08-18
45141SUPPL2016-08-18
40076SUPPL2015-06-05
32125SUPPL2015-05-13
43369ORIG2014-06-24
24397ORIG2014-06-24
19027ORIG2013-08-21
9914ORIG2013-08-20
32124ORIG2013-06-11
32123ORIG2012-06-26