Application 016080
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MANNITOL 5% | MANNITOL | INJECTABLE;INJECTION | 5GM/100ML | No | No |
| 002 | MANNITOL 10% | MANNITOL | INJECTABLE;INJECTION | 10GM/100ML | No | No |
| 003 | MANNITOL 15% | MANNITOL | INJECTABLE;INJECTION | 15GM/100ML | No | No |
| 004 | MANNITOL 20% | MANNITOL | INJECTABLE;INJECTION | 20GM/100ML | No | No |
| 005 | MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% | MANNITOL | INJECTABLE;INJECTION | 15GM/100ML | No | No |
| 006 | MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER | MANNITOL | INJECTABLE;INJECTION | 10GM/100ML | No | No |
| 007 | MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% | MANNITOL | INJECTABLE;INJECTION | 5GM/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016080-001 | MANNITOL 5% | MANNITOL | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N016080-002 | MANNITOL 10% | MANNITOL | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N016080-003 | MANNITOL 15% | MANNITOL | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N016080-004 | MANNITOL 20% | MANNITOL | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N016080-005 | MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% | MANNITOL | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N016080-006 | MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER | MANNITOL | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N016080-007 | MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% | MANNITOL | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N016080-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N016080-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N016080-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N016080-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N016080-005 | MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N016080-006 | MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N016080-007 | MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016080-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016080-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016080-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016080-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016080-005 | MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016080-006 | MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016080-007 | MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016080-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016080-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016080-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016080-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016080-005 | MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016080-006 | MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016080-007 | MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016080-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016080-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016080-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016080-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016080-005 | MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016080-006 | MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016080-007 | MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016080-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016080-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016080-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016080-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016080-005 | MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016080-006 | MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016080-007 | MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016080-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016080-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016080-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016080-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016080-005 | MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… |
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 |
|---|---|---|---|---|---|---|
| Aridol Bronchial Challenge Test Kit | MANNITOL | Methapharm, Inc. | 5387a4fb-b894-4cba-88a3-a947217d34da | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | MANNITOL |
| Mannitol | MANNITOL | Hospira, Inc. | 8ad3145e-00e7-4412-b9a5-06f00f264f30 | 2026-04-21 | Warnings, Adverse reactions | MANNITOL |
| Mannitol | MANNITOL | ProPharma Distribution | 430669d7-9ad1-9a04-e063-6394a90ababb | 2025-11-07 | Warnings, Adverse reactions | MANNITOL |
| Mannitol | MANNITOL | ICU Medical Inc. | ba7bf864-8a4d-4262-8fd1-00174fa2f9d1 | 2025-10-24 | Warnings, Adverse reactions | MANNITOL |
| Osmitrol | MANNITOL | Baxter Healthcare Company | 0d914965-7001-45cb-ba51-d7c5964b05bc | 2025-08-26 | Warnings, Adverse reactions | MANNITOL |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | MANNITOL |
| MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | 999ce711-2d5b-0d7d-e053-2995a90a2689 | 2024-01-27 | Warnings, Adverse reactions | MANNITOL |
| Mannitol | MANNITOL | B. Braun Medical Inc. | d12cc802-b538-4065-a264-f474ff3b3043 | 2023-08-15 | Warnings, Adverse reactions | MANNITOL |
| Mannitol | MANNITOL | Fresenius Kabi USA, LLC | c395e13d-6ea1-4104-8b37-669cfb982f04 | 2023-03-16 | Warnings, Adverse reactions | MANNITOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.