FDA.reportPublic FDA data

Application 208223

Type
NDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEMBRACE SYMTOUCHSUMATRIPTAN SUCCINATESOLUTION;SUBCUTANEOUSEQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N208223-001ZEMBRACE SYMTOUCH (AUTOINJECTOR)SUMATRIPTAN SUCCINATEEQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2016-01-28

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208223-001105375542036-01-29U-722020-01-21
N208223-001113642242036-01-29U-722022-06-21
N208223-001120971832036-01-29Drug product2024-10-24

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N208223-001ZEMBRACE SYMTOUCHEQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSRLD2016-01-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208223-001ZEMBRACE SYMTOUCHEQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSRLD2016-01-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208223-001ZEMBRACE SYMTOUCHEQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSRLD2016-01-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N208223-001ZEMBRACE SYMTOUCHEQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSRLD2016-01-28a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 83 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N208223-001105375542036-01-29U-722020-01-21c2088c7a36db…
2026-10-15 13:18:302026-09N208223-001113642242036-01-29U-722022-06-21c2088c7a36db…
2026-10-15 13:18:302026-09N208223-001120971832036-01-29Drug product2024-10-24c2088c7a36db…
2026-09-14 22:38:342026-08N208223-001105375542036-01-29U-722020-01-2184e616aacf4f…
2026-09-14 22:38:342026-08N208223-001113642242036-01-29U-722022-06-2184e616aacf4f…
2026-09-14 22:38:342026-08N208223-001120971832036-01-29Drug product2024-10-2484e616aacf4f…
2026-08-18 06:07:402026-07N208223-001105375542036-01-29U-722020-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07N208223-001113642242036-01-29U-722022-06-21caaa826d4ba7…
2026-08-18 06:07:402026-07N208223-001120971832036-01-29Drug product2024-10-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208223-001105375542036-01-29U-722020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208223-001113642242036-01-29U-722022-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208223-001120971832036-01-29Drug product2024-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208223-001105375542036-01-29U-722020-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208223-001113642242036-01-29U-722022-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208223-001120971832036-01-29Drug product2024-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N208223-001105375542036-01-29U-722020-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208223-001113642242036-01-29U-722022-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208223-001120971832036-01-29Drug product2024-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208223-001105375542036-01-29U-722020-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208223-001113642242036-01-29U-722022-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208223-001120971832036-01-29Drug product2024-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208223-001105375542036-01-29U-722020-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208223-001113642242036-01-29U-722022-06-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208223-001120971832036-01-29Drug product2024-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208223-001105375542036-01-29U-722020-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208223-001113642242036-01-29U-722022-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208223-001120971832036-01-29Drug product2024-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208223-001105375542036-01-29U-722020-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208223-001113642242036-01-29U-722022-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208223-001120971832036-01-29Drug product2024-10-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208223-001105375542036-01-29U-722020-01-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208223-001113642242036-01-29U-722022-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208223-001105375542036-01-29U-722020-01-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208223-001113642242036-01-29U-722022-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208223-001120971832036-01-29Drug product2024-10-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208223-001105375542036-01-29U-722020-01-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N208223-001113642242036-01-29U-722022-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208223-001105375542036-01-29U-722020-01-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208223-001113642242036-01-29U-722022-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208223-001105375542036-01-29U-722020-01-21301d65b070ca…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zembrace SymTouchSUMATRIPTAN SUCCINATETonix Medicines, Inc.3eb49807-fa9d-4a0d-9a3c-76de5b23b01b2025-02-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 208223
application number: NDA208223

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
0245-0809ZEMBRACE SYMTOUCHSumatriptan SuccinateUpsher-Smith laboratories, LLCNDACurrent
0245-0809ZEMBRACE SYMTOUCHSumatriptan SuccinateUpsher-Smith laboratories, LLCNDACurrent
0245-0809ZEMBRACE SYMTOUCHSumatriptan SuccinateUpsher-Smith laboratories, LLCNDACurrent
67857-809ZEMBRACE SymTouchsumatriptanPromius Pharma, LLCNDACurrent
67857-809ZEMBRACE SymTouchsumatriptanPromius Pharma, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59014SUPPL2019-06-12
59011SUPPL2019-06-11
50197ORIG2017-10-26
47692SUPPL2017-03-28
47626SUPPL2017-03-28
40627ORIG2016-02-11
32899ORIG2016-02-01