FDA.reportPublic FDA data

Application 205394

Type
NDA
Sponsor
GENSCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIZAFILMRIZATRIPTAN BENZOATEFILM;ORALEQ 10MG BASEYesNo
002RIZAFILMRIZATRIPTAN BENZOATEFILM;ORALEQ 5MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205394-001RIZAFILMRIZATRIPTAN BENZOATEEQ 10MG BASEFILM / ORALRLD2023-04-14
N205394-002RIZAFILMRIZATRIPTAN BENZOATEEQ 5MG BASEFILM / ORALRLD, RS2026-02-26

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205394-00193019482034-07-30Drug substance, Drug product2023-07-26

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD, RS2023-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD, RS2023-04-148072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD, RS2023-04-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD, RS2023-04-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD, RS2023-04-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD, RS2023-04-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD, RS2023-04-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD, RS2023-04-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD, RS2023-04-143f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N205394-001RIZAFILMEQ 10MG BASEFILM / ORALRLD2023-04-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N205394-002RIZAFILMEQ 5MG BASEFILM / ORALRLD, RS2026-02-26a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N205394-00193019482034-07-30Drug substance, Drug product2023-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205394-00193019482034-07-30Drug substance, Drug product2023-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N205394-00193019482034-07-30Drug substance, Drug product2023-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205394-00193019482034-07-30Drug substance, Drug product2023-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205394-00193019482034-07-30Drug substance, Drug product2023-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205394-00193019482034-07-30Drug substance, Drug product2023-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205394-00193019482034-07-30Drug substance, Drug product2023-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205394-00193019482034-07-30Drug substance, Drug product2023-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205394-00193019482034-07-30Drug substance, Drug product2023-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205394-00193019482034-07-30Drug substance, Drug product2023-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205394-00193019482034-07-30Drug substance, Drug product2023-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205394-00193019482034-07-30Drug substance, Drug product2023-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205394-00193019482034-07-30Drug substance, Drug product2023-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205394-00193019482034-07-30Drug substance, Drug product2023-07-268072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205394-00193019482034-07-30Drug substance, Drug product2023-07-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205394-00193019482034-07-30Drug substance, Drug product2023-07-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205394-00193019482034-07-30Drug substance, Drug product2023-07-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205394-00193019482034-07-30Drug substance, Drug product2023-07-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205394-00193019482034-07-30Drug substance, Drug product2023-07-269b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N205394-00193019482034-07-30Drug substance, Drug product2023-07-26a50c72e98297…

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
RIZAFILMRIZATRIPTAN BENZOATEGensco Laboratories LLCfa32794e-d26d-e0bf-e053-6294a90abb0e2025-04-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 205394
application number: NDA205394

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85187SUPPL 2026-03-02
85186SUPPL 2026-03-02
84883SUPPL 2026-01-30
84882SUPPL 2026-01-30
76776SUPPL 2023-12-12
76774SUPPL 2023-12-12
74757ORIG 2023-07-14
74009ORIG 2023-04-17
74003ORIG 2023-04-17