Application 016080

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
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.

Product history page 5 of 8 · 308 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2021-12-28 21:50 UTC	2021-12	N016080-007	MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016080-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016080-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016080-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016080-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016080-005	MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%	15GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016080-006	MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER	10GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016080-007	MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016080-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016080-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016080-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016080-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016080-005	MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%	15GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016080-006	MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER	10GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016080-007	MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016080-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016080-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016080-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016080-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016080-005	MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%	15GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016080-006	MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER	10GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016080-007	MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016080-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016080-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016080-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016080-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016080-005	MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%	15GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016080-006	MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER	10GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016080-007	MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016080-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016080-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016080-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016080-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016080-005	MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%	15GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016080-006	MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER	10GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016080-007	MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016080-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016080-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016080-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016080-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`

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.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	Hospira, Inc.	8ad3145e-00e7-4412-b9a5-06f00f264f30	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	ProPharma Distribution	430669d7-9ad1-9a04-e063-6394a90ababb	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	ICU Medical Inc.	ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Osmitrol	MANNITOL	Baxter Healthcare Company	0d914965-7001-45cb-ba51-d7c5964b05bc	2025-08-26	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	Henry Schein, Inc.	e2444db1-9dfe-451f-a33c-9b00786464d2	2025-05-20	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
MANNITOL	MANNITOL	HF Acquisition Co LLC, DBA HealthFirst	999ce711-2d5b-0d7d-e053-2995a90a2689	2024-01-27	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	B. Braun Medical Inc.	d12cc802-b538-4065-a264-f474ff3b3043	2023-08-15	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	Fresenius Kabi USA, LLC	c395e13d-6ea1-4104-8b37-669cfb982f04	2023-03-16	Warnings, Adverse reactions	Name fallback generic name: MANNITOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.