Application 019603

Type: NDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MANNITOL 5% IN PLASTIC CONTAINER	MANNITOL	INJECTABLE;INJECTION	5GM/100ML	No	No
002	MANNITOL 10% IN PLASTIC CONTAINER	MANNITOL	INJECTABLE;INJECTION	10GM/100ML	No	No
003	MANNITOL 15% IN PLASTIC CONTAINER	MANNITOL	INJECTABLE;INJECTION	15GM/100ML	No	No
004	MANNITOL 20% IN PLASTIC CONTAINER	MANNITOL	INJECTABLE;INJECTION	20GM/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	MANNITOL	5GM/100ML	INJECTABLE / INJECTION		1987-01-08
N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	MANNITOL	10GM/100ML	INJECTABLE / INJECTION		1987-01-08
N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	MANNITOL	15GM/100ML	INJECTABLE / INJECTION		1990-01-08
N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	MANNITOL	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019603-004	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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019603-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019603-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019603-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019603-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019603-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019603-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019603-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019603-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019603-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019603-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019603-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019603-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019603-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019603-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019603-004	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019603-004	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019603-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019603-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019603-004	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019603-004	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019603-004	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019603-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019603-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019603-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019603-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019603-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019603-004	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019603-004	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019603-004	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019603-004	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019603-004	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019603-004	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019603-004	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019603-004	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019603-004	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019603-004	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019603-004	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019603-004	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019603-004	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019603-004	AP	1	`e64feba35796…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mannitol	MANNITOL	ICU Medical Inc.	ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019603 application number: NDA019603 ndc (product): 0990-7715

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7715	Mannitol	MANNITOL	Hospira, Inc.	NDA	Current
0409-7715	Mannitol	MANNITOL	Hospira, Inc.	NDA	Current
0990-7715	Mannitol	MANNITOL	ICU Medical Inc.	NDA	Current
0990-7715	Mannitol	MANNITOL	ICU Medical Inc.	NDA	Current
0990-7715	Mannitol	MANNITOL	ICU Medical Inc.	NDA	Current
0990-7715	Mannitol	MANNITOL	ICU Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62760	SUPPL	2020-04-30
62750	SUPPL	2020-04-30
57169	SUPPL	2019-01-10