Home Applications 050596 Application 050596
Type NDA
Sponsor US PHARM HOLDINGS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 20MG BASE/ML No No 002 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 20MG BASE/ML No No 003 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 40MG BASE/ML No No 004 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 40MG BASE/ML No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050596-001 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 20MG BASE/ML INJECTABLE / INJECTION 1985-05-20 N050596-002 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 20MG BASE/ML INJECTABLE / INJECTION 1985-05-20 N050596-003 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 40MG BASE/ML INJECTABLE / INJECTION 1985-05-20 N050596-004 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 40MG BASE/ML INJECTABLE / INJECTION 1985-05-20
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 5 of 5 · 172 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 2022-09-29 23:25 UTC 2022-09 N050596-001 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1985-05-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050596-002 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1985-05-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050596-003 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1985-05-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050596-004 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1985-05-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050596-001 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1985-05-20 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050596-002 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1985-05-20 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050596-003 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1985-05-20 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050596-004 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1985-05-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050596-001 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1985-05-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050596-002 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION 1985-05-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050596-003 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1985-05-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050596-004 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION 1985-05-20 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 17915 SUPPL 2015-04-14 30142 SUPPL 2015-03-24 30141 SUPPL 2014-02-25 17914 SUPPL 2014-02-25 39023 SUPPL 2011-09-16 7867 SUPPL 2011-09-13 7866 SUPPL 2009-06-02 39022 SUPPL 2008-02-25 7865 SUPPL 2008-02-25 30140 SUPPL 2004-06-24 7864 SUPPL 2002-01-18