Application 206369

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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% (10ML)	No	No
002	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (20ML)	No	No

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

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
A206369-001	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2015-09-02
A206369-002	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A			2015-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206369-001	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 2 · 79 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
2026-02-19 14:30 UTC	2026-02	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206369-001	STERILE WATER FOR INJECTION	100%	LIQUID / N/A	AP	2015-09-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A206369-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206369-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206369-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206369-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206369-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206369-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206369-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206369-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206369-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206369-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206369-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206369-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206369-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206369-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206369-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206369-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206369-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206369-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206369-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206369-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206369-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206369-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206369-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206369-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206369-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206369-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206369-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206369-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206369-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206369-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206369-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206369-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206369-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206369-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206369-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206369-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206369-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206369-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206369-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206369-001	AP	1	`cb3db0bc1861…`

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
Sterile Water	WATER INJECTION	Henry Schein, Inc.	3501952b-b556-4d5e-b81b-5c35ff87b475	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206369 application number: ANDA206369
Sterile Water	WATER	Hikma Pharmaceuticals USA Inc.	78ef7ad3-451d-43d0-a9b6-5cf0aadca003	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206369 application number: ANDA206369 ndc (product): 0641-6147
Sterile Water	WATER	Civica, Inc.	3f49eedf-5bf5-4a95-b704-c956d860ca04	2023-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206369 application number: ANDA206369 ndc (product): 72572-747

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6147	Sterile Water	WATER	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6147	Sterile Water	WATER	West-Ward Pharmaceuticals Corp.	ANDA	Current
52584-147	Sterile Water	Sterile Water	General Injectables and Vaccines, Inc.	ANDA	Current
72572-747	Sterile Water	WATER	Civica, Inc.	ANDA	Current
72572-747	Sterile Water	WATER	Civica, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19720	ORIG	2015-10-22
32803	ORIG	2015-09-04