FDA.reportPublic FDA data

Application 213244

Type
ANDA
Sponsor
EUGIA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATESOLUTION;INTRAVENOUS5MG/10ML (0.5MG/ML)NoNo
002NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATESOLUTION;INTRAVENOUS10MG/10ML (1MG/ML)NoNo
003NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATEINJECTABLE;INJECTION5MG/10ML(0.5MG/ML)NoNo
004NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATEINJECTABLE;INJECTION10MG/10ML(1MG/ML)NoNo

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
A213244-001NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02
A213244-002NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02

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 UTC2026-02A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2023-11-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2023-11-028072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2023-11-026a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2023-11-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2023-11-021c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2023-11-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2023-11-02ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2023-11-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2023-11-02a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2023-11-02a72a2bbeb626…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A213244-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213244-002AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213244-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213244-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213244-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213244-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213244-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213244-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213244-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213244-002AP1a72a2bbeb626…

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
NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATEEugia US LLCc5729883-88d7-40fe-8fe4-fe39204ccb302024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213244
application number: ANDA213244