Application 210064

Type
NDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEPOWDER;INTRAVENOUSEQ 150MG BASE/VIALNoNo

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

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
N210064-001FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05

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 UTC2026-02N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-053f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-053f0d92c62455…
2023-05-13 08:27 UTC2023-05N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05053a50430f4f…
2023-01-26 05:58 UTC2023-01N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N210064-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUS2019-09-05a50c72e98297…

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
FosaprepitantFOSAPREPITANTActavis Pharma, Inc.9dbd4c29-d894-4839-9b22-a2f65c8c8ad12022-06-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 210064
application number: NDA210064
ndc (product): 0591-4385

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-4385FosaprepitantfosaprepitantActavis Pharma, Inc.NDACurrent
0591-4385FosaprepitantfosaprepitantActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62206ORIG2020-03-19
59936ORIG2019-09-06
50057ORIG2019-09-06