Home Applications 019631 Application 019631
Type NDA
Sponsor B BRAUN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;110MG/100ML No No 002 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;200MG/100ML No No 003 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;330MG/100ML No No 004 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;450MG/100ML No No 005 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;900MG/100ML No No 006 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;110MG/100ML No No 007 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;200MG/100ML No No 008 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;330MG/100ML No No 009 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;450MG/100ML No No 010 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;900MG/100ML No No 011 DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;110MG/100ML No No 012 DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;200MG/100ML No No 013 DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;330MG/100ML No No 014 DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;450MG/100ML No No 015 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;900MG/100ML No No 016 DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.3GM/100ML;300MG/100ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 16 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019631-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-002 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-003 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-004 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 N019631-005 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-006 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-007 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;200MG/100ML INJECTABLE / INJECTION AP 1988-02-24 N019631-008 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;330MG/100ML INJECTABLE / INJECTION AP 1988-02-24 N019631-009 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 N019631-010 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;900MG/100ML INJECTABLE / INJECTION AP 1988-02-24 N019631-011 DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-012 DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-013 DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-014 DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;450MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-015 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-016 DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 3.3GM/100ML;300MG/100ML INJECTABLE / INJECTION 1990-01-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 18 · 704 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 2026-10-15 13:18:30 2026-09 N019631-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 2.5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-002 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 2.5GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-003 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 2.5GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-004 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-005 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 2.5GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-006 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-007 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION AP 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-008 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION AP 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-009 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-010 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5GM/100ML;900MG/100ML INJECTABLE / INJECTION AP 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-011 DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 10GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-012 DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 10GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-013 DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 10GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-014 DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10GM/100ML;450MG/100ML INJECTABLE / INJECTION 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-015 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 10GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019631-016 DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 3.3GM/100ML;300MG/100ML INJECTABLE / INJECTION 1990-01-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 N019631-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 2.5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-002 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 2.5GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-003 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 2.5GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-004 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-005 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 2.5GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-006 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-007 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION AP 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-008 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION AP 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-009 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-010 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5GM/100ML;900MG/100ML INJECTABLE / INJECTION AP 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-011 DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 10GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-012 DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 10GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-013 DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 10GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-014 DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10GM/100ML;450MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-015 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 10GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-016 DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 3.3GM/100ML;300MG/100ML INJECTABLE / INJECTION 1990-01-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019631-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 2.5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-002 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 2.5GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-003 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 2.5GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-004 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-005 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 2.5GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-006 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-007 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION AP 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-008 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION AP 1988-02-24 caaa826d4ba7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 220 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0264-7605 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7608 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7608 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7610 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7610 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7612 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7612 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7614 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7614 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7616 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7616 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7622 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7622 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7623 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current 0264-7623 Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE B. Braun Medical Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 33817 SUPPL 2004-09-29 17494 SUPPL 2004-09-29