Home Applications 088911 Application 088911
Type ANDA
Sponsor FRESENIUS KABI USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML No No 002 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;INJECTION 90MG/10ML (9MG/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 270MG/30ML (9MG/ML) SOLUTION / INJECTION AP 1985-02-07 A088911-002 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 1985-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 of 2 · 66 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 2020-12-22 03:56 UTC 2020-12 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 270MG/30ML (9MG/ML) SOLUTION / INJECTION AP 1985-02-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088911-002 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 1985-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 270MG/30ML (9MG/ML) SOLUTION / INJECTION AP 1985-02-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A088911-002 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 1985-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 270MG/30ML (9MG/ML) SOLUTION / INJECTION AP 1985-02-07 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A088911-002 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 1985-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 270MG/30ML (9MG/ML) SOLUTION / INJECTION AP 1985-02-07 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088911-002 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 1985-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 270MG/30ML (9MG/ML) SOLUTION / INJECTION AP 1985-02-07 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088911-002 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 1985-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 270MG/30ML (9MG/ML) SOLUTION / INJECTION AP 1985-02-07 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088911-002 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 1985-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP 1985-02-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A088911-001 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 270MG/30ML (9MG/ML) SOLUTION / INJECTION AP 1985-02-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A088911-002 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 1985-05-17 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 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.
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 63323-924 Bacteriostatic Sodium Chloride SODIUM CHLORIDE Fresenius Kabi USA, LLC ANDA Current 63323-924 Bacteriostatic Sodium Chloride SODIUM CHLORIDE APP Pharmaceuticals, LLC ANDA Current 63323-924 Bacteriostatic Sodium Chloride SODIUM CHLORIDE Fresenius Kabi USA, LLC ANDA Current 70529-049 Corvatrol 0.9% SODIUM CHLORIDE IT3 Medical LLC ANDA Current 70529-049 Corvatrol 0.9% SODIUM CHLORIDE IT3 Medical LLC ANDA Current