Home Applications 062422 Application 062422
Type ANDA
Sponsor BAXTER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM INJECTABLE;INJECTION EQ 20MG BASE/ML No No 002 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM INJECTABLE;INJECTION EQ 40MG BASE/ML No No 003 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM INJECTABLE;INJECTION EQ 20MG BASE/ML No No 004 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM INJECTABLE;INJECTION EQ 40MG BASE/ML No No 005 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM INJECTABLE;INJECTION EQ 20MG BASE/ML No No 006 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM INJECTABLE;INJECTION EQ 40MG BASE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062422-001 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 A062422-002 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 A062422-003 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 A062422-004 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 A062422-005 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM EQ 20MG BASE/ML INJECTABLE / INJECTION 1991-07-16 A062422-006 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER CEPHALOTHIN SODIUM EQ 40MG BASE/ML INJECTABLE / INJECTION 1991-07-16
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 4 of 7 · 264 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2019-12-13 00:20 UTC 2019-12 A062422-001 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062422-002 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062422-003 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062422-004 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062422-005 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1991-07-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062422-006 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1991-07-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062422-001 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062422-002 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062422-003 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062422-004 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062422-005 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1991-07-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062422-006 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1991-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062422-001 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A062422-002 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A062422-003 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A062422-004 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A062422-005 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1991-07-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A062422-006 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1991-07-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062422-001 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062422-002 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062422-003 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062422-004 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062422-005 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1991-07-16 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062422-006 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1991-07-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062422-001 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A062422-002 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A062422-003 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A062422-004 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A062422-005 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1991-07-16 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A062422-006 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1991-07-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062422-001 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A062422-002 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A062422-003 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A062422-004 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A062422-005 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1991-07-16 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A062422-006 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1991-07-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062422-001 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A062422-002 CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A062422-003 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1984-01-31 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A062422-004 CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1984-01-31 c0c555d07b60…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.