Application 062564

Type
ANDA
Sponsor
APOTHECON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KANTREXKANAMYCIN SULFATEINJECTABLE;INJECTIONEQ 75MG BASE/2MLNoNo
002KANTREXKANAMYCIN SULFATEINJECTABLE;INJECTIONEQ 500MG BASE/2MLNoNo
003KANTREXKANAMYCIN SULFATEINJECTABLE;INJECTIONEQ 1GM BASE/3MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062564-001KANTREXKANAMYCIN SULFATEEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-21
A062564-002KANTREXKANAMYCIN SULFATEEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-21
A062564-003KANTREXKANAMYCIN SULFATEEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-21

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062564-002KANTREXEQ 500MG BASE/2MLINJECTABLE / INJECTION1984-09-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062564-003KANTREXEQ 1GM BASE/3MLINJECTABLE / INJECTION1984-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062564-001KANTREXEQ 75MG BASE/2MLINJECTABLE / INJECTION1984-09-211e350fbaab3a…