Application 018801

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (1ML)	Yes	No
002	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (10ML)	Yes	Yes
003	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (20ML)	Yes	Yes
004	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (50ML)	Yes	Yes
005	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (100ML)	Yes	Yes
006	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (5.2ML)	Yes	Yes

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

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
N018801-001	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	1982-10-27
N018801-002	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27
N018801-003	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27
N018801-004	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (50ML)	LIQUID / N/A		RLD, RS	1982-10-27
N018801-005	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (100ML)	LIQUID / N/A		RLD, RS	1982-10-27
N018801-006	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (5.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD, RS	2023-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018801-002	AP
N018801-003	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 6 · 215 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
2026-02-19 14:30 UTC	2026-02	N018801-001	STERILE WATER FOR INJECTION	100% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	1982-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018801-002	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018801-003	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018801-004	STERILE WATER FOR INJECTION	100% (50ML)	LIQUID / N/A		RLD, RS	1982-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018801-005	STERILE WATER FOR INJECTION	100% (100ML)	LIQUID / N/A		RLD, RS	1982-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018801-006	STERILE WATER FOR INJECTION	100% (5.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD, RS	2023-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018801-001	STERILE WATER FOR INJECTION	100% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	1982-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018801-002	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018801-003	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018801-004	STERILE WATER FOR INJECTION	100% (50ML)	LIQUID / N/A		RLD, RS	1982-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018801-005	STERILE WATER FOR INJECTION	100% (100ML)	LIQUID / N/A		RLD, RS	1982-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018801-006	STERILE WATER FOR INJECTION	100% (5.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD, RS	2023-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018801-001	STERILE WATER FOR INJECTION	100% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	1982-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018801-002	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018801-003	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018801-004	STERILE WATER FOR INJECTION	100% (50ML)	LIQUID / N/A		RLD, RS	1982-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018801-005	STERILE WATER FOR INJECTION	100% (100ML)	LIQUID / N/A		RLD, RS	1982-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018801-006	STERILE WATER FOR INJECTION	100% (5.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	2023-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018801-001	STERILE WATER FOR INJECTION	100% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	1982-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018801-002	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018801-003	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018801-004	STERILE WATER FOR INJECTION	100% (50ML)	LIQUID / N/A		RLD, RS	1982-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018801-005	STERILE WATER FOR INJECTION	100% (100ML)	LIQUID / N/A		RLD, RS	1982-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018801-006	STERILE WATER FOR INJECTION	100% (5.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	2023-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018801-001	STERILE WATER FOR INJECTION	100% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	1982-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018801-002	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018801-003	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018801-004	STERILE WATER FOR INJECTION	100% (50ML)	LIQUID / N/A		RLD, RS	1982-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018801-005	STERILE WATER FOR INJECTION	100% (100ML)	LIQUID / N/A		RLD, RS	1982-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018801-006	STERILE WATER FOR INJECTION	100% (5.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	2023-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018801-001	STERILE WATER FOR INJECTION	100% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	1982-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018801-002	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018801-003	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018801-004	STERILE WATER FOR INJECTION	100% (50ML)	LIQUID / N/A		RLD, RS	1982-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018801-005	STERILE WATER FOR INJECTION	100% (100ML)	LIQUID / N/A		RLD, RS	1982-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018801-006	STERILE WATER FOR INJECTION	100% (5.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	2023-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018801-001	STERILE WATER FOR INJECTION	100% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIQUID / N/A		RLD	1982-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018801-002	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018801-003	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A	AP	RLD, RS	1982-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018801-004	STERILE WATER FOR INJECTION	100% (50ML)	LIQUID / N/A		RLD, RS	1982-10-27	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 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	N018801-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018801-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018801-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018801-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018801-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018801-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018801-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018801-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018801-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018801-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018801-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018801-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018801-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018801-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018801-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018801-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018801-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018801-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018801-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018801-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018801-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018801-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018801-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018801-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018801-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018801-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018801-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018801-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018801-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018801-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018801-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018801-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018801-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018801-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018801-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018801-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018801-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018801-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018801-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018801-001	AP	1	`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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Cardinal Health 107, LLC	9655cd02-82b5-4a75-813b-854b19551481	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801 ndc (product): 55154-0127
Sterile Water	WATER	Hospira, Inc.	3a6422e1-feee-4095-8883-2b0837039e6e	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801
Sterile Water	WATER	Hospira, Inc.	2b9ea23a-f9e9-48a8-25b7-519e3bbd6828	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801 ndc (product): 0409-4887
Sterile Water	WATER	ProPharma Distribution	386a0a2f-4ff7-f128-e063-6294a90a7d4d	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801
STERILE WATER	WATER	Henry Schein, Inc.	f4087143-9868-4308-b96c-43657ee8ec28	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801 ndc (product): 0404-9971
Sterile Water	WATER	Henry Schein, Inc.	88403fcf-a276-42c0-88b6-bd84a720b564	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801 ndc (product): 0404-9959
STERILE WATER	STERILE WATER	HF Acquisition Co. LLC, DBA HealthFirst	74ed2a6f-824c-a1ff-e053-2a91aa0a57c0	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801 ndc (product): 51662-1266
STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b83	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801 ndc (product): 51662-1329
STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	7610bf80-61b7-982f-e053-2a91aa0ac1bb	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801 ndc (product): 51662-1265
STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	99b1cb12-0b2d-0c0f-e053-2a95a90ac3b6	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801 ndc (product): 51662-1474
Sterile Water	WATER	A-S Medication Solutions	dba87371-31d2-47c2-ab83-89aabce4b184	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801 ndc (product): 50090-2874
Sterile Water	WATER	Medical Purchasing Solutions, LLC	e90b47e3-9636-b9ee-e053-2a95a90ad48c	2022-09-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018801 application number: NDA018801 ndc (product): 76420-082

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9959	Sterile Water	Water	Henry Schein, Inc.	NDA	Current
0404-9971	STERILE WATER	WATER	Henry Schein, Inc.	NDA	Current
0404-9971	STERILE WATER	WATER	Henry Schein, Inc.	NDA	Current
0409-4887	Sterile Water	WATER	Hospira, Inc.	NDA	Current
0409-4887	Sterile Water	WATER	Hospira, Inc.	NDA	Current
0409-4887	Sterile Water	WATER	Hospira, Inc.	NDA	Current
50090-2874	Sterile Water	WATER	A-S Medication Solutions	NDA	Current
50090-2874	Sterile Water	WATER	A-S Medication Solutions	NDA	Current
50090-2874	Sterile Water	WATER	A-S Medication Solutions	NDA	Current
50090-2874	Sterile Water	WATER	A-S Medication Solutions	NDA	Current
51662-1265	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1265	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1265	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1266	STERILE WATER	STERILE WATER	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1266	STERILE WATER	STERILE WATER	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1266	STERILE WATER	STERILE WATER	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1329	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1329	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1329	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1474	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1474	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-079	STERILE WATER	WATER	General Injectables and Vaccines, Inc.	NDA	Current
52584-079	STERILE WATER	WATER	General Injectables and Vaccines, Inc.	NDA	Current
52584-079	STERILE WATER	WATER	General Injectables and Vaccines, Inc.	NDA	Current
52584-079	STERILE WATER	WATER	General Injectables and Vaccines, Inc.	NDA	Current
52584-079	STERILE WATER	WATER	General Injectables and Vaccines, Inc.	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
55154-0127	Sterile Water	WATER	Cardinal Health	NDA	Current
55154-0127	Sterile Water	WATER	Cardinal Health	NDA	Current
55154-2379	Sterile Water	WATER	Cardinal Health	NDA	Current
55154-2379	Sterile Water	WATER	Cardinal Health	NDA	Current
64725-4887	Sterile Water	WATER	TYA Pharmaceuticals	NDA	Current
71872-7041	Sterile Water	WATER	Medical Purchasing Solutions, LLC	NDA	Current
71872-7182	Sterile Water	WATER	Medical Purchasing Solutions, LLC	NDA	Current
76420-082	Sterile Water	WATER	Asclemed USA, Inc.	NDA	Current
76420-082	Sterile Water	WATER	Asclemed USA, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
16057	SUPPL	2009-07-08
16056	SUPPL	2004-04-20