Application 209296

Type
NDA
Sponsor
HERON THERAPS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CINVANTIAPREPITANTEMULSION;INTRAVENOUS130MG/18ML (7.2MG/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N209296-001CINVANTIAPREPITANT130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209296-001105002082035-09-18Drug product2019-12-23
N209296-001106248502035-09-18U-21612020-04-30
N209296-001109530182035-09-18U-21612021-04-08
N209296-001111731182035-09-18Drug product2021-12-13
N209296-001117448002035-09-18Drug product2023-10-02
N209296-001121152542035-09-18Drug product2024-11-07
N209296-001121152552035-09-18Drug product2024-11-07
N209296-001122905202035-09-18Drug product2025-05-12
N209296-00195612292035-09-18U-2161Drug product2017-12-05
N209296-00198084652035-09-18U-21612017-12-05
N209296-00199747422035-09-18Drug product2018-06-19
N209296-00199747932035-09-18Drug product2018-06-19
N209296-00199747942035-09-18U-2161Drug product2018-06-19

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-093f01610625f2…
2019-09-15 20:21 UTC2019-09N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09b00525d2431f…
2019-07-19 19:46 UTC2019-07N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-093f0d92c62455…
2023-05-13 08:27 UTC2023-05N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09053a50430f4f…
2023-01-26 05:58 UTC2023-01N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209296-001CINVANTI130MG/18ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2017-11-09e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 10 · 397 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N209296-001105002082035-09-18Drug product2019-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-001106248502035-09-18U-21612020-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-001109530182035-09-18U-21612021-04-08caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-001111731182035-09-18Drug product2021-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-001117448002035-09-18Drug product2023-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-001121152542035-09-18Drug product2024-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-001121152552035-09-18Drug product2024-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-001122905202035-09-18Drug product2025-05-12caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-00195612292035-09-18U-2161Drug product2017-12-05caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-00198084652035-09-18U-21612017-12-05caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-00199747422035-09-18Drug product2018-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-00199747932035-09-18Drug product2018-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07N209296-00199747942035-09-18U-2161Drug product2018-06-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209296-001105002082035-09-18Drug product2019-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-001106248502035-09-18U-21612020-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-001109530182035-09-18U-21612021-04-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-001111731182035-09-18Drug product2021-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-001117448002035-09-18Drug product2023-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-001121152542035-09-18Drug product2024-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-001121152552035-09-18Drug product2024-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-001122905202035-09-18Drug product2025-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-00195612292035-09-18U-2161Drug product2017-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-00198084652035-09-18U-21612017-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-00199747422035-09-18Drug product2018-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-00199747932035-09-18Drug product2018-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209296-00199747942035-09-18U-2161Drug product2018-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-001105002082035-09-18Drug product2019-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-001106248502035-09-18U-21612020-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-001109530182035-09-18U-21612021-04-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-001111731182035-09-18Drug product2021-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-001117448002035-09-18Drug product2023-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-001121152542035-09-18Drug product2024-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-001121152552035-09-18Drug product2024-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-001122905202035-09-18Drug product2025-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-00195612292035-09-18U-2161Drug product2017-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-00198084652035-09-18U-21612017-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-00199747422035-09-18Drug product2018-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-00199747932035-09-18Drug product2018-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209296-00199747942035-09-18U-2161Drug product2018-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N209296-001105002082035-09-18Drug product2019-12-236a471c1ec25d…

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
CINVANTIAPREPITANTHeron Therapeutics, Inc.4c218d3a-a508-4abc-9ed8-a6e8e191d1b42026-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 209296
application number: NDA209296
ndc (product): 47426-201

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47426-201CINVANTIaprepitantHeron Therapeutics, Inc.NDACurrent
47426-201CINVANTIaprepitantHeron Therapeutics, Inc.NDACurrent
47426-201CINVANTIaprepitantHeron Therapeutics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77721SUPPL 2024-03-05
77716SUPPL 2024-03-05
70796SUPPL2022-04-20
70522SUPPL2022-03-15
60632SUPPL2019-10-22
60630SUPPL2019-10-22
57833SUPPL2019-02-28
57823SUPPL2019-02-27
52881ORIG2018-03-09
50385ORIG2017-11-13
50368ORIG2017-11-13