Home Applications 091387 Application 091387
Type ANDA
Sponsor B BRAUN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BALANCED SALT CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE SOLUTION;IRRIGATION 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091387-001 BALANCED SALT CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2010-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091387-001 AT
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 2 · 44 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 A091387-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2010-02-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091387-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2010-02-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091387-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2010-02-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A091387-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2010-02-03 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Balanced Salt SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE B. Braun Medical Inc. 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 2024-03-13 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091387 application number: ANDA091387 ndc (product): 0264-1945
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0264-1945 Balanced Salt Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate B. Braun Medical Inc. ANDA Current 0264-1945 Balanced Salt Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate B. Braun Medical Inc. ANDA Current 0264-2514 Balanced Salt Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate B. Braun Medical Inc. ANDA Current 0264-2514 Balanced Salt Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate B. Braun Medical Inc. ANDA Current 0264-2514 Balanced Salt Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate B. Braun Medical Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9335 ORIG 2010-02-17