Application 016269
- Type
- NDA
- Sponsor
- HOSPIRA
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 25% | MANNITOL | INJECTABLE;INJECTION | 12.5GM/50ML | No | No |
| 006 | MANNITOL 25% | MANNITOL | INJECTABLE;INJECTION | 12.5GM/50ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016269-001 | MANNITOL 5% | MANNITOL | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N016269-002 | MANNITOL 10% | MANNITOL | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N016269-003 | MANNITOL 15% | MANNITOL | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N016269-004 | MANNITOL 20% | MANNITOL | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N016269-005 | MANNITOL 25% | MANNITOL | 12.5GM/50ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N016269-006 | MANNITOL 25% | MANNITOL | 12.5GM/50ML | INJECTABLE / INJECTION | AP | 1994-08-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N016269-006 | AP |
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 | N016269-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016269-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016269-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016269-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016269-005 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016269-006 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | AP | 1994-08-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N016269-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016269-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016269-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016269-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016269-005 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016269-006 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | AP | 1994-08-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016269-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016269-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016269-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016269-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016269-005 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016269-006 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | AP | 1994-08-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016269-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016269-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016269-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016269-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016269-005 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016269-006 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | AP | 1994-08-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016269-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016269-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016269-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016269-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016269-005 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016269-006 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | AP | 1994-08-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016269-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016269-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016269-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016269-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016269-005 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016269-006 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | AP | 1994-08-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016269-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016269-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016269-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016269-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | N016269-006 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N016269-006 | AP | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N016269-006 | AP | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Mannitol | MANNITOL | Hospira, Inc. | 8ad3145e-00e7-4412-b9a5-06f00f264f30 | 2026-04-21 | Warnings, Adverse reactions | 016269 NDA016269 0409-4031 |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | 016269 NDA016269 0404-9905 |
| MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | 999ce711-2d5b-0d7d-e053-2995a90a2689 | 2024-01-27 | Warnings, Adverse reactions | 016269 NDA016269 51662-1468 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0404-9905 | Mannitol | Mannitol | Henry Schein, Inc. | NDA | Current |
| 0404-9905 | Mannitol | Mannitol | Henry Schein, Inc. | NDA | Current |
| 0409-4031 | Mannitol | MANNITOL | Hospira, Inc. | NDA | Current |
| 0409-4031 | Mannitol | MANNITOL | Hospira, Inc. | NDA | Current |
| 0409-4031 | Mannitol | MANNITOL | Hospira, Inc. | NDA | Current |
| 0409-4031 | Mannitol | MANNITOL | Hospira, Inc. | NDA | Current |
| 0409-4031 | Mannitol | MANNITOL | Hospira, Inc. | NDA | Current |
| 51662-1468 | MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1468 | MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1468 | MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 52584-031 | Mannitol | Mannitol | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-031 | Mannitol | Mannitol | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-031 | Mannitol | Mannitol | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-031 | Mannitol | Mannitol | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-031 | Mannitol | Mannitol | General Injectables & Vaccines, Inc | NDA | Current |