Application 062723

Type
ANDA
Sponsor
ABRAXIS PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEPHAPIRIN SODIUMCEPHAPIRIN SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002CEPHAPIRIN SODIUMCEPHAPIRIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
003CEPHAPIRIN SODIUMCEPHAPIRIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo
004CEPHAPIRIN SODIUMCEPHAPIRIN SODIUMINJECTABLE;INJECTIONEQ 4GM BASE/VIALNoNo
005CEPHAPIRIN SODIUMCEPHAPIRIN SODIUMINJECTABLE;INJECTIONEQ 20GM BASE/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062723-001CEPHAPIRIN SODIUMCEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-17
A062723-002CEPHAPIRIN SODIUMCEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-17
A062723-003CEPHAPIRIN SODIUMCEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-17
A062723-004CEPHAPIRIN SODIUMCEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-17
A062723-005CEPHAPIRIN SODIUMCEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-17

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 2 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-171e350fbaab3a…

Reported adverse events (FAERS/openFDA)#

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