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 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-17c2088c7a36db…
2026-10-15 13:18:302026-09A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-17c2088c7a36db…
2026-10-15 13:18:302026-09A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-17c2088c7a36db…
2026-10-15 13:18:302026-09A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-17c2088c7a36db…
2026-10-15 13:18:302026-09A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-17c2088c7a36db…
2026-09-14 22:38:342026-08A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-1784e616aacf4f…
2026-09-14 22:38:342026-08A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-1784e616aacf4f…
2026-09-14 22:38:342026-08A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-1784e616aacf4f…
2026-09-14 22:38:342026-08A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-1784e616aacf4f…
2026-09-14 22:38:342026-08A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-1784e616aacf4f…
2026-08-18 06:07:402026-07A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062723-001CEPHAPIRIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1986-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062723-002CEPHAPIRIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062723-003CEPHAPIRIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062723-004CEPHAPIRIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1986-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062723-005CEPHAPIRIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTION1986-11-17b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

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