Application 018632

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	LIQUID;N/A	100%	Yes	Yes
002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	LIQUID;N/A	100%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30
N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N018632-001	AP
N018632-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N018632-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018632-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018632-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018632-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018632-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018632-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018632-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018632-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018632-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018632-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018632-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018632-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018632-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018632-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018632-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018632-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018632-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018632-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018632-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018632-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018632-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018632-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018632-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018632-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018632-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018632-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018632-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018632-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018632-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018632-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018632-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018632-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018632-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018632-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018632-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018632-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018632-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018632-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018632-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018632-002	AP	1	`74a2ff9319b5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018632 application number: NDA018632 ndc (product): 0338-0013
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018632 application number: NDA018632 ndc (product): 0338-0013

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0013	Sterile Water	Water	Baxter Healthcare Company	NDA	Current
0338-0013	Sterile Water	Water	Baxter Healthcare Company	NDA	Current
0338-0013	Sterile Water	Water	Baxter Healthcare Company	NDA	Current
0338-0013	Sterile Water	Water	Baxter Healthcare Company	NDA	Current
0338-0013	Sterile Water	Water	Baxter Healthcare Company	NDA	Current
0338-0013	Sterile Water	Water	Baxter Healthcare Company	NDA	Current
0338-0013	Sterile Water	Water	Baxter Healthcare Company	NDA	Current
0338-0013	Sterile Water	Water	Baxter Healthcare Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33527	SUPPL	2016-06-01
15051	SUPPL	2016-05-31