FDA.reportPublic FDA data

Application 078244

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEONDANSETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2MG BASE/MLNoNo

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
A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-233f01610625f2…
2019-09-15 20:21 UTC2019-09A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078244-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-04-23cb3db0bc1861…

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
ondansetron hydrochlorideONDANSETRON HYDROCHLORIDEOnesource Specialty Pharma Limited438c3d28-8bed-50f0-e063-6394a90a18e42025-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078244
application number: ANDA078244

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
82449-200ondansetron hydrochlorideondansetron hydrochlorideSteriscience Specialties Private LimitedANDACurrent