Home Applications 217535 Application 217535
Type ANDA
Sponsor NEXUS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE SOLUTION;INJECTION 90MG/10ML (9MG/ML) No No 002 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE SOLUTION;INJECTION 180MG/20ML (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 A217535-001 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 A217535-002 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23
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 1 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 2026-09-14 22:38:34 2026-08 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217535-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217535-002 SODIUM CHLORIDE 0.9% 180MG/20ML (9MG/ML) SOLUTION / INJECTION AP 2023-08-23 a72a2bbeb626…
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 5 of 9 · 176 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate Sterile Saline Mist SODIUM CHLORIDE WALMART INC. 275ada29-8904-fe1e-e063-6394a90abe59 2025-01-24 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Baxter Healthcare Corporation 93aeac13-41de-4452-9f38-d6b4f38ada30 2025-01-24 Name fallback generic name: SODIUM CHLORIDE D-129 SODIUM CHLORIDE DNA Labs, Inc. ef130f08-1c34-4774-9298-2d1997e631fc 2025-01-13 Warnings Name fallback generic name: SODIUM CHLORIDE SODIUM CHLORIDE SODIUM CHLORIDE HF Acquisition Co LLC, DBA HealthFirst 998a2a47-5c79-2efd-e053-2995a90a8fac 2025-01-08 Adverse reactions Name fallback generic name: SODIUM CHLORIDE SODIUM CHLORIDE SODIUM CHLORIDE HF Acquisition Co LLC, DBA HealthFirst 7da788fc-3481-527f-e053-2a91aa0af6ac 2025-01-08 Adverse reactions Name fallback generic name: SODIUM CHLORIDE DG Health Sterile Saline Mist SODIUM CHLORIDE DG Health f2e44ab4-ae0f-c87b-e053-2a95a90acd04 2024-12-31 Warnings Name fallback generic name: SODIUM CHLORIDE Sterile Hypertonic Saline Solution 7 Sodium Chloride SODIUM CHLORIDE JOONEM LLC e7110525-9f9b-5b68-e053-2995a90ac034 2024-12-23 Warnings Name fallback generic name: SODIUM CHLORIDE Base Laboratories Saline SODIUM CHLORIDE Joonem LLC 49309411-9af4-4f19-a3bf-dbeabc106827 2024-12-23 Warnings Name fallback generic name: SODIUM CHLORIDE Base Laboratories Saline SODIUM CHLORIDE Joonem LLC ba0868f6-d3de-40e2-bcb3-144fa53062c7 2024-12-23 Warnings Name fallback generic name: SODIUM CHLORIDE Base Laboratories Saline SODIUM CHLORIDE Joonem LLC 9d83f477-ebbc-4248-8445-769178181d4f 2024-12-23 Warnings Name fallback generic name: SODIUM CHLORIDE Ancient Secrets Breathe Again SODIUM CHLORIDE LOTUS BRANDS, INC. c6d2bab0-d363-4c09-a71b-ae15db915b37 2024-12-18 Warnings Name fallback generic name: SODIUM CHLORIDE Walgreens Saline Mist Extra Strength SODIUM CHLORIDE Walgreen's Corporation 90cbe2dc-36b6-77fb-e053-2995a90a2897 2024-12-18 Warnings Name fallback generic name: SODIUM CHLORIDE CVS Health Sterile Saline Mist SODIUM CHLORIDE CVS Pharmacy 6f1fe980-ca09-401d-aed6-d3d3387cc49a 2024-12-18 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Baxter Healthcare Company 464c2d78-5c88-4668-a039-56dd3c1c9b20 2024-12-03 Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Baxter Healthcare Corporation aaab14e7-a4b4-4b2b-8d73-ba688064a9b1 2024-11-21 Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Baxter Healthcare Company 99a15716-bbb9-4e33-a48d-20c58b81f392 2024-11-13 Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Hospira, Inc. 8eb172da-dcd4-4660-4a8f-ad44a14b4af7 2024-11-06 Adverse reactions Name fallback generic name: SODIUM CHLORIDE Licefreee SODIUM CHLORIDE Tec Laboratories, Inc. 40b8dd81-fd8b-602e-e054-00144ff8d46c 2024-11-05 Warnings Name fallback generic name: SODIUM CHLORIDE Licefreee Everyday SODIUM CHLORIDE Tec Laboratories,Inc. 407b5fd6-2331-2ba7-e054-00144ff88e88 2024-11-05 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Fresenius Kabi USA, LLC c44b0fdb-33df-4747-b443-5fb4deb456cb 2024-10-11 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE
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 75302 ORIG 2023-08-28