Application 016269

Type: NDA
Sponsor: HOSPIRA

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 25%	MANNITOL	INJECTABLE;INJECTION	12.5GM/50ML	No	No
006	MANNITOL 25%	MANNITOL	INJECTABLE;INJECTION	12.5GM/50ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
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#

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

Application-product, TE code table
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.

Product history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`

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	N016269-006	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016269-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016269-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016269-006	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016269-006	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016269-006	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016269-006	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016269-006	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016269-006	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016269-006	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016269-006	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016269-006	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016269-006	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016269-006	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016269-006	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016269-006	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016269-006	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016269-006	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016269-006	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016269-006	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016269-006	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016269-006	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016269-006	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016269-006	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016269-006	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016269-006	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016269-006	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016269-006	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016269-006	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016269-006	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016269-006	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016269-006	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016269-006	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016269-006	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016269-006	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016269-006	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016269-006	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016269-006	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 · 3 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 016269 application number: NDA016269 ndc (product): 0409-4031
Mannitol	MANNITOL	Henry Schein, Inc.	e2444db1-9dfe-451f-a33c-9b00786464d2	2025-05-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016269 application number: NDA016269 ndc (product): 0404-9905
MANNITOL	MANNITOL	HF Acquisition Co LLC, DBA HealthFirst	999ce711-2d5b-0d7d-e053-2995a90a2689	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016269 application number: NDA016269 ndc (product): 51662-1468

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62195	SUPPL	2020-03-19
62187	SUPPL	2020-03-18
57334	SUPPL	2019-01-23
57171	SUPPL	2019-01-10