Application 013684

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N013684-001	OSMITROL 5% IN WATER	MANNITOL	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N013684-002	OSMITROL 10% IN WATER	MANNITOL	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N013684-003	OSMITROL 20% IN WATER	MANNITOL	20GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N013684-004	OSMITROL 15% IN WATER	MANNITOL	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N013684-005	OSMITROL 5% IN WATER IN PLASTIC CONTAINER	MANNITOL	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N013684-006	OSMITROL 10% IN WATER IN PLASTIC CONTAINER	MANNITOL	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N013684-007	OSMITROL 20% IN WATER IN PLASTIC CONTAINER	MANNITOL	20GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N013684-008	OSMITROL 15% IN WATER IN PLASTIC CONTAINER	MANNITOL	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
N013684-001	AP
N013684-002	AP
N013684-003	AP
N013684-004	AP
N013684-005	AP
N013684-006	AP
N013684-007	AP
N013684-008	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 9 · 328 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N013684-001	OSMITROL 5% IN WATER	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-002	OSMITROL 10% IN WATER	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-003	OSMITROL 20% IN WATER	20GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-004	OSMITROL 15% IN WATER	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-005	OSMITROL 5% IN WATER IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-006	OSMITROL 10% IN WATER IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-007	OSMITROL 20% IN WATER IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-008	OSMITROL 15% IN WATER IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-001	OSMITROL 5% IN WATER	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-002	OSMITROL 10% IN WATER	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-003	OSMITROL 20% IN WATER	20GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-004	OSMITROL 15% IN WATER	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-005	OSMITROL 5% IN WATER IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-006	OSMITROL 10% IN WATER IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-007	OSMITROL 20% IN WATER IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-008	OSMITROL 15% IN WATER IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013684-001	OSMITROL 5% IN WATER	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-002	OSMITROL 10% IN WATER	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-003	OSMITROL 20% IN WATER	20GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-004	OSMITROL 15% IN WATER	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-005	OSMITROL 5% IN WATER IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-006	OSMITROL 10% IN WATER IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-007	OSMITROL 20% IN WATER IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-008	OSMITROL 15% IN WATER IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-001	OSMITROL 5% IN WATER	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-002	OSMITROL 10% IN WATER	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-003	OSMITROL 20% IN WATER	20GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-004	OSMITROL 15% IN WATER	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-005	OSMITROL 5% IN WATER IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-006	OSMITROL 10% IN WATER IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-007	OSMITROL 20% IN WATER IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-008	OSMITROL 15% IN WATER IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-001	OSMITROL 5% IN WATER	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-002	OSMITROL 10% IN WATER	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-003	OSMITROL 20% IN WATER	20GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-004	OSMITROL 15% IN WATER	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-005	OSMITROL 5% IN WATER IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-006	OSMITROL 10% IN WATER IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-007	OSMITROL 20% IN WATER IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-008	OSMITROL 15% IN WATER IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N013684-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013684-008	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013684-008	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013684-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013684-008	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-006	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-007	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013684-008	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-006	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-007	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013684-008	AP	1	`b8a1b40f171c…`

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
Osmitrol	MANNITOL	Baxter Healthcare Company	0d914965-7001-45cb-ba51-d7c5964b05bc	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 013684 application number: NDA013684 ndc (product): 0338-0353 ndc (product): 0338-0357

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0351	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0351	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0353	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0353	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0353	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0353	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0353	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0355	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0355	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0355	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0355	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0355	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0357	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0357	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0357	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0357	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current
0338-0357	Osmitrol	Mannitol	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59583	SUPPL	2019-08-06
59604	SUPPL	2019-08-05
56544	SUPPL	2018-11-23
56543	SUPPL	2018-11-23
56488	SUPPL	2018-11-16
56486	SUPPL	2018-11-16
12053	SUPPL	2005-09-07
10833	SUPPL	2005-09-07
33108	SUPPL	2005-06-14
12052	SUPPL	2005-06-14