Application 202832
- Type
- NDA
- Sponsor
- MEDEFIL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 9MG/ML (9MG/ML) | Yes | No |
| 002 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 18MG/2ML (9MG/ML) | Yes | No |
| 003 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 22.5MG/2.5ML (9MG/ML) | Yes | No |
| 004 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 27MG/3ML (9MG/ML) | Yes | No |
| 005 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 45MG/5ML (9MG/ML) | Yes | No |
| 006 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 90MG/10ML (9MG/ML) | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202832-001 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 9MG/ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | |
| N202832-002 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 18MG/2ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | |
| N202832-003 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 22.5MG/2.5ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | |
| N202832-004 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 27MG/3ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | |
| N202832-005 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 45MG/5ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | |
| N202832-006 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202832-005 | SODIUM CHLORIDE 0.9% | 45MG/5ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202832-006 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202832-001 | SODIUM CHLORIDE 0.9% | 9MG/ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202832-002 | SODIUM CHLORIDE 0.9% | 18MG/2ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202832-003 | SODIUM CHLORIDE 0.9% | 22.5MG/2.5ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202832-004 | SODIUM CHLORIDE 0.9% | 27MG/3ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202832-005 | SODIUM CHLORIDE 0.9% | 45MG/5ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202832-006 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202832-001 | SODIUM CHLORIDE 0.9% | 9MG/ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202832-002 | SODIUM CHLORIDE 0.9% | 18MG/2ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202832-003 | SODIUM CHLORIDE 0.9% | 22.5MG/2.5ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202832-004 | SODIUM CHLORIDE 0.9% | 27MG/3ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202832-005 | SODIUM CHLORIDE 0.9% | 45MG/5ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202832-006 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202832-001 | SODIUM CHLORIDE 0.9% | 9MG/ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202832-002 | SODIUM CHLORIDE 0.9% | 18MG/2ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202832-003 | SODIUM CHLORIDE 0.9% | 22.5MG/2.5ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202832-004 | SODIUM CHLORIDE 0.9% | 27MG/3ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202832-005 | SODIUM CHLORIDE 0.9% | 45MG/5ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202832-006 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202832-001 | SODIUM CHLORIDE 0.9% | 9MG/ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202832-002 | SODIUM CHLORIDE 0.9% | 18MG/2ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202832-003 | SODIUM CHLORIDE 0.9% | 22.5MG/2.5ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202832-004 | SODIUM CHLORIDE 0.9% | 27MG/3ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202832-005 | SODIUM CHLORIDE 0.9% | 45MG/5ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202832-006 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202832-001 | SODIUM CHLORIDE 0.9% | 9MG/ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202832-002 | SODIUM CHLORIDE 0.9% | 18MG/2ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202832-003 | SODIUM CHLORIDE 0.9% | 22.5MG/2.5ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202832-004 | SODIUM CHLORIDE 0.9% | 27MG/3ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202832-005 | SODIUM CHLORIDE 0.9% | 45MG/5ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202832-006 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N202832-001 | SODIUM CHLORIDE 0.9% | 9MG/ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N202832-002 | SODIUM CHLORIDE 0.9% | 18MG/2ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N202832-003 | SODIUM CHLORIDE 0.9% | 22.5MG/2.5ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N202832-004 | SODIUM CHLORIDE 0.9% | 27MG/3ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N202832-005 | SODIUM CHLORIDE 0.9% | 45MG/5ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N202832-006 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | INJECTABLE / INJECTION | RLD, RS | 2012-01-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202832-001 | SODIUM CHLORIDE 0.9% | 9MG/ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202832-002 | SODIUM CHLORIDE 0.9% | 18MG/2ML (9MG/ML) | INJECTABLE / INJECTION | RLD | 2012-01-06 | 79d66fd596c7… |
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 | Medefil, Inc. | d1468c0f-dd4f-4d38-a84c-c1d110303965 | 2026-02-26 | Warnings, Adverse reactions | 202832 NDA202832 64253-202 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.