Application 088909
- Type
- ANDA
- Sponsor
- ABRAXIS PHARM
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | ||
| A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 |
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.
| 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 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | 1985-02-07 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A088909-002 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | 1985-05-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 9MG/ML | INJECTABLE / INJECTION | 1985-02-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 9MG/ML | INJECTABLE / INJECTION | 1985-02-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 9MG/ML | INJECTABLE / INJECTION | 1985-02-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 9MG/ML | INJECTABLE / INJECTION | 1985-02-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 9MG/ML | INJECTABLE / INJECTION | 1985-02-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 9MG/ML | INJECTABLE / INJECTION | 1985-02-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 9MG/ML | INJECTABLE / INJECTION | 1985-02-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A088909-001 | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 9MG/ML | INJECTABLE / INJECTION | 1985-02-07 | 5aa47cf7b7d7… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | 97007188-43fe-416c-a87b-6ccc4d9ae2ec | 2025-10-29 | Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride Normal Salt | SODIUM CHLORIDE | Method Pharmaceuticals | ce84727a-3677-4bf0-e053-2995a90a3ec8 | 2025-10-21 | Warnings | SODIUM CHLORIDE |
| Walgreens | SODIUM CHLORIDE | Walgreen Company | 21dfc2cf-65ae-c3fb-e063-6294a90a0a94 | 2025-10-17 | SODIUM CHLORIDE | |
| Sodium chloride | SODIUM CHLORIDE | Becton Dickinson and Company | ca3355f2-2cf0-4f58-bed5-0c4c0a7d3511 | 2025-10-08 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| QUALITY CHOICE SALINE | SODIUM CHLORIDE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | f51491d8-12ad-4b1b-a171-c621bfdcc341 | 2025-08-12 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Henry Schein, Inc. | e0466bb3-6c26-4044-b051-69f48b67f632 | 2025-08-07 | Adverse reactions | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | 9e72418a-376e-4637-99ad-d13c904a7986 | 2025-07-30 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Nextgen Pharmaceuticals LLC | 28f79c75-82d2-4912-81fc-a723b5ccf4c1 | 2025-07-23 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| BACTERIOSTATIC SODIUM CHLORIDE | SODIUM CHLORIDE | ProPharma Distribution | 3868864f-4f46-d2a1-e063-6394a90a65d5 | 2025-07-18 | Boxed warning, Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 0d59a04a-32e6-485b-b638-a1e6c09e9642 | 2025-07-09 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Normal Salt | SODIUM CHLORIDE | Twin Med LLC | dc82ff0f-8600-373a-e053-2995a90a7505 | 2025-07-03 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride Normal Salt | SODIUM CHLORIDE | Advanced Rx LLC | 40f471b7-27cf-4ad4-aef6-cc9d0623ddd9 | 2025-07-02 | Warnings | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | 958d35f0-6834-43be-a700-fa58f38b4c19 | 2025-06-30 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 6d43fa91-0940-437f-ba70-b2d3f977593e | 2025-04-25 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Nat Mur 6X | SODIUM CHLORIDE | Hyland's Inc. | dcf0e2ac-3b69-3ae4-e053-2a95a90aaf41 | 2025-04-10 | Warnings | SODIUM CHLORIDE |
| HYDRA NEB | SODIUM CHLORIDE | Venture Healthcare Ltd | 30b184bf-2451-d96b-e063-6294a90a43c7 | 2025-03-19 | Warnings | SODIUM CHLORIDE |
| HYDRA NEB | SODIUM CHLORIDE | Laboratoire Unither | 30b244c0-84bb-a0a0-e063-6394a90a9dee | 2025-03-19 | Warnings | SODIUM CHLORIDE |
| Natrum Muriaticum 6X | SODIUM CHLORIDE | SEVENE USA | ff0d279e-210a-6f8a-e053-6294a90a11dc | 2025-02-11 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride Normal Salt | SODIUM CHLORIDE | Citragen Pharmaceuticals Inc | aae783b2-18fe-69ca-e053-2a95a90a0800 | 2025-01-30 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride Normal Salt | SODIUM CHLORIDE | Citragen Pharmaceuticals Inc | 82c29f1d-a018-7483-e053-2a91aa0a8f7e | 2025-01-30 | Warnings | SODIUM CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.