Application 062466

Type
ANDA
Sponsor
INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KANAMYCIN SULFATEKANAMYCIN SULFATEINJECTABLE;INJECTIONEQ 500MG BASE/2MLNoNo
002KANAMYCIN SULFATEKANAMYCIN SULFATEINJECTABLE;INJECTIONEQ 1GM BASE/3MLNoNo

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
A062466-001KANAMYCIN SULFATEKANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-30
A062466-002KANAMYCIN SULFATEKANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-30

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 22:38:342026-08A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-3084e616aacf4f…
2026-08-18 06:07:402026-07A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062466-001KANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1983-09-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062466-002KANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1983-09-3074a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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