Home Applications 050792 Application 050792
Type NDA
Sponsor B BRAUN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 2GM BASE No No 002 CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 1GM BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050792-001 CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 2GM BASE INJECTABLE / INJECTION 2004-07-29 N050792-002 CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 1GM BASE INJECTABLE / INJECTION 2004-07-29
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 3 of 3 · 88 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 2022-10-28 04:53 UTC 2022-10 N050792-001 CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER EQ 2GM BASE INJECTABLE / INJECTION 2004-07-29 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050792-002 CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER EQ 1GM BASE INJECTABLE / INJECTION 2004-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050792-001 CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER EQ 2GM BASE INJECTABLE / INJECTION 2004-07-29 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050792-002 CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER EQ 1GM BASE INJECTABLE / INJECTION 2004-07-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050792-001 CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER EQ 2GM BASE INJECTABLE / INJECTION 2004-07-29 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050792-002 CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER EQ 1GM BASE INJECTABLE / INJECTION 2004-07-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050792-001 CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER EQ 2GM BASE INJECTABLE / INJECTION 2004-07-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050792-002 CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER EQ 1GM BASE INJECTABLE / INJECTION 2004-07-29 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 18263 SUPPL 2007-09-11 8300 SUPPL 2007-09-11 22242 ORIG 2006-07-28 30563 ORIG 2004-08-02 18262 ORIG 2004-08-02