FDA.reportPublic FDA data

Application 018885

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMBOLEXDIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLNoNo
002EMBOLEXDIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N018885-001EMBOLEXDIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-30
N018885-002EMBOLEXDIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-30

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-3084e616aacf4f…
2026-09-14 22:38:342026-08N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-3084e616aacf4f…
2026-08-18 06:07:402026-07N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018885-001EMBOLEX0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5MLINJECTABLE / INJECTION1984-11-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018885-002EMBOLEX0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7MLINJECTABLE / INJECTION1984-11-3074a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.