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 44.

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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062426-001CEPHALOTHINEQ 500MG BASE/VIALINJECTABLE / INJECTION1985-05-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062426-002CEPHALOTHINEQ 1GM BASE/VIALINJECTABLE / INJECTION1985-05-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062426-003CEPHALOTHINEQ 2GM BASE/VIALINJECTABLE / INJECTION1985-05-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062426-004CEPHALOTHINEQ 4GM BASE/VIALINJECTABLE / INJECTION1985-05-034b0b4de00fa7…

Reported adverse events (FAERS/openFDA)#

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