Application 062426

Type
ANDA
Sponsor
INTL MEDICATION

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062426-001CEPHALOTHINCEPHALOTHIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-03
A062426-002CEPHALOTHINCEPHALOTHIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-03
A062426-003CEPHALOTHINCEPHALOTHIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-03
A062426-004CEPHALOTHINCEPHALOTHIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-03

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-0384e616aacf4f…
2026-09-14 22:38:342026-08A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-0384e616aacf4f…
2026-09-14 22:38:342026-08A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-0384e616aacf4f…
2026-09-14 22:38:342026-08A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-0384e616aacf4f…
2026-08-18 06:07:402026-07A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-03caaa826d4ba7…
2026-08-18 06:07:402026-07A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-03caaa826d4ba7…
2026-08-18 06:07:402026-07A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-03caaa826d4ba7…
2026-08-18 06:07:402026-07A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-035bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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