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 |
|---|---|---|---|---|---|---|
| Bacteriostatic Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | e5e325d1-0d58-40c9-9645-3ae402ff9d92 | 2024-10-11 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | cc3d5bc8-9d3c-4c65-9e43-707a2db4081a | 2024-09-25 | Warnings | SODIUM CHLORIDE |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | 93fafa27-5031-4d95-b4b8-5574b7204ae2 | 2024-09-25 | Warnings | SODIUM CHLORIDE |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | 454f337e-d897-46de-ab05-1c543a33061c | 2024-09-25 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | f55bd888-5e01-474d-871b-24654c070178 | 2024-07-24 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 83994d0c-8484-4505-abb5-8a384ed12288 | 2024-07-22 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| sodium chloride | SODIUM CHLORIDE | Becton Dickinson and Company | 8df7dcf6-8714-6caf-e053-2995a90ab8cc | 2024-07-15 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | CODAN US CORPORATION | aa06e286-75c6-4d7a-959f-6008d38aa6e5 | 2024-06-24 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 239a5af1-7498-480f-862c-ab7c3d89d183 | 2024-05-21 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Becton Dickinson and Company | ebc8b008-a8b3-4c41-89e4-b413f7aab89f | 2024-05-21 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 47a0313f-36df-4fa6-a828-c9e1946ba9b0 | 2024-05-08 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 7f22c06b-6b4d-4b49-a4b2-d2169f2bd653 | 2024-05-07 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | f2475fa3-ab1d-4b81-8127-b58cd0790a54 | 2024-05-06 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | c1e52670-c85e-4f19-a2e9-bf9abd7c3727 | 2024-04-23 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Hikma Pharmaceuticals USA Inc. | e5ee8caa-b6ca-45ba-98fb-8305e6282141 | 2024-04-10 | Adverse reactions | SODIUM CHLORIDE |
| CVS Health Sterile Saline Mist | SODIUM CHLORIDE | CVS Pharmacy | 14931004-1efb-e331-e063-6294a90ad66e | 2024-03-26 | Warnings | SODIUM CHLORIDE |
| Aqua marina | SODIUM CHLORIDE | Boiron | 14945760-30b5-27d3-e063-6394a90a8a32 | 2024-03-26 | SODIUM CHLORIDE | |
| Natrum Muriaticum | SODIUM CHLORIDE | SEVENE USA | 11008014-fff6-4d5a-8c5c-a20443d7cc23 | 2024-01-30 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Spectra Medical Deviecs, LLC | 7e316d21-d6ad-4976-bd90-268fd7e51361 | 2024-01-12 | Adverse reactions | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 037ac04d-f8f3-4bb8-993a-ac8f7683ff83 | 2024-01-04 | Warnings, Adverse reactions | SODIUM CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.