Application 206099

Type
NDA
Sponsor
CURRAX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONZETRA XSAILSUMATRIPTAN SUCCINATEPOWDER;NASALEQ 11MG BASEYesYes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206099-001ONZETRA XSAILSUMATRIPTAN SUCCINATEEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206099-001115715312026-02-23U-18092023-05-19
N206099-001101241322027-03-06U-1719Drug product2018-12-10
N206099-001101241322027-03-06U-2010Drug product2018-12-10
N206099-001101241322027-03-06U-2011Drug product2018-12-10
N206099-001103988592027-12-19Drug product2019-09-30
N206099-00188757042028-04-07U-1809Drug product2016-02-23
N206099-001107226672028-12-30Drug product2020-08-25
N206099-001100766152029-07-30U-20102018-10-12
N206099-001100766152029-07-30U-20112018-10-12
N206099-001100766152029-07-30U-24042018-10-12
N206099-00185500732029-10-22Drug product2016-02-23
N206099-00188992292030-08-18Drug product2016-02-23
N206099-00196494562030-10-21U-1719Drug product2017-05-26
N206099-00196494562030-10-21U-2010Drug product2017-05-26
N206099-00196494562030-10-21U-2011Drug product2017-05-26
N206099-00189786472030-12-06Drug product2016-02-23
N206099-001104785742033-11-04U-24042019-12-09
N206099-001100766142034-10-20Drug product2018-10-12

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-2784e616aacf4f…
2026-08-18 06:07:402026-07N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-273f01610625f2…
2019-09-15 20:21 UTC2019-09N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / INHALATIONRLD, RS2016-01-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / INHALATIONRLD, RS2016-01-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206099-001ONZETRA XSAILEQ 11MG BASEPOWDER / NASALRLD, RS2016-01-27f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 24 · 958 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N206099-001115715312026-02-23U-18092023-05-1984e616aacf4f…
2026-09-14 22:38:342026-08N206099-001101241322027-03-06U-2010Drug product2018-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N206099-001101241322027-03-06U-1719Drug product2018-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N206099-001101241322027-03-06U-2011Drug product2018-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N206099-001103988592027-12-19Drug product2019-09-3084e616aacf4f…
2026-09-14 22:38:342026-08N206099-00188757042028-04-07U-1809Drug product2016-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N206099-001107226672028-12-30Drug product2020-08-2584e616aacf4f…
2026-09-14 22:38:342026-08N206099-001100766152029-07-30U-20112018-10-1284e616aacf4f…
2026-09-14 22:38:342026-08N206099-001100766152029-07-30U-20102018-10-1284e616aacf4f…
2026-09-14 22:38:342026-08N206099-001100766152029-07-30U-24042018-10-1284e616aacf4f…
2026-09-14 22:38:342026-08N206099-00185500732029-10-22Drug product2016-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N206099-00188992292030-08-18Drug product2016-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N206099-00196494562030-10-21U-1719Drug product2017-05-2684e616aacf4f…
2026-09-14 22:38:342026-08N206099-00196494562030-10-21U-2011Drug product2017-05-2684e616aacf4f…
2026-09-14 22:38:342026-08N206099-00196494562030-10-21U-2010Drug product2017-05-2684e616aacf4f…
2026-09-14 22:38:342026-08N206099-00189786472030-12-06Drug product2016-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N206099-001104785742033-11-04U-24042019-12-0984e616aacf4f…
2026-09-14 22:38:342026-08N206099-001100766142034-10-20Drug product2018-10-1284e616aacf4f…
2026-08-18 06:07:402026-07N206099-001115715312026-02-23U-18092023-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-001101241322027-03-06U-2010Drug product2018-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-001101241322027-03-06U-1719Drug product2018-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-001101241322027-03-06U-2011Drug product2018-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-001103988592027-12-19Drug product2019-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-00188757042028-04-07U-1809Drug product2016-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-001107226672028-12-30Drug product2020-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-001100766152029-07-30U-20112018-10-12caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-001100766152029-07-30U-20102018-10-12caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-001100766152029-07-30U-24042018-10-12caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-00185500732029-10-22Drug product2016-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-00188992292030-08-18Drug product2016-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-00196494562030-10-21U-1719Drug product2017-05-26caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-00196494562030-10-21U-2011Drug product2017-05-26caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-00196494562030-10-21U-2010Drug product2017-05-26caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-00189786472030-12-06Drug product2016-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-001104785742033-11-04U-24042019-12-09caaa826d4ba7…
2026-08-18 06:07:402026-07N206099-001100766142034-10-20Drug product2018-10-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206099-001115715312026-02-23U-18092023-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206099-001101241322027-03-06U-2010Drug product2018-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206099-001101241322027-03-06U-1719Drug product2018-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206099-001101241322027-03-06U-2011Drug product2018-12-10011fe1cb6892…

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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rxf6c907a3-9624-f893-e053-6294a90a31af2025-01-22Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.7628caf4-5272-4e42-e053-2a91aa0a2f242025-01-08Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2a96f37d-03f6-678c-e063-6394a90ae0c62024-12-31Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLC5d1f3de0-684a-4092-be30-aa325ff20d042024-12-18Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLCda77dfc4-551c-4e0e-a65e-cb478f193cd92024-12-18Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rx284ee7ac-759e-b592-e063-6394a90a78ba2024-12-02Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.b297a466-7d24-9ebd-e053-2a95a90af4d12024-07-17Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.54c6f8f4-5466-3988-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.933f6575-a4c4-0f65-e053-2a95a90ab9672024-06-19Name fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.85295be9-852d-4e21-e053-2991aa0a8a782024-06-14Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEFresenius Kabi USA, LLCb183c7ba-2cc6-4854-a9a6-71ccd35925862024-04-12Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
sumatriptan succinateSUMATRIPTAN SUCCINATEA-S Medication Solutions97016a59-3b49-4134-85aa-8c866f2856012023-11-22Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENorthStar Rx LLC38fd19bf-b7aa-812c-8a74-2414dfec45f42023-03-01Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPfe09fab6-b9e3-469c-9a38-bcc343dcc8992023-01-01Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEAsclemed USA, Inc.77f9f135-e840-48f0-81e8-73e08433e7682022-10-11Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPabbd2168-1523-4eb6-a75c-dc4d7d1b1c9b2022-06-01Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LP1042b91c-715c-4e90-b9cc-d91a17f9f7cb2022-04-01Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
sumatriptan succinateSUMATRIPTAN SUCCINATEProficient Rx LP9f4d487a-c5f7-4707-976b-64e738c98d452022-04-01Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddy's Laboratories Limited4e26764d-ce26-e5ac-e6db-0f1f7a1d5c2b2021-12-21Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEXellia Pharmaceuticals USA LLCf42c6e00-e693-48f3-8e84-c3f139e1adf52021-11-18Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42847-311Onzetra Xsailsumatriptan succinateCurrax Pharmaceuticals LLCNDACurrent
42847-311Onzetra Xsailsumatriptan succinateCurrax Pharmaceuticals LLCNDACurrent
42847-311Onzetra Xsailsumatriptan succinateCurrax Pharmaceuticals LLCNDACurrent
64597-311ONZETRAsumatriptan succinateAvanir Pharmaceuticals, Inc.NDACurrent
64597-311ONZETRAsumatriptan succinateAvanir Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61445SUPPL2019-12-26
61394SUPPL2019-12-23
59132SUPPL2019-06-20
59121SUPPL2019-06-19
23012ORIG2016-07-19
19705ORIG2016-02-18
10545ORIG2016-01-29