Application 211188

Type: ANDA
Sponsor: MEDEFIL INC

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)	No	No
002	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (2.5ML)	No	Yes
003	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (3ML)	No	Yes
004	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (5ML)	No	Yes
005	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (10ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211188-001	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02
A211188-002	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02
A211188-003	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02
A211188-004	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02
A211188-005	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211188-004	AP
A211188-005	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 · 205 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
2026-10-15 13:18:30	2026-09	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A211188-004	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211188-005	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211188-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211188-005	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211188-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211188-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211188-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211188-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211188-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211188-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211188-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211188-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211188-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211188-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211188-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211188-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211188-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211188-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211188-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211188-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211188-004	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211188-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211188-004	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211188-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211188-004	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211188-005	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211188-004	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211188-005	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211188-004	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211188-005	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211188-004	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211188-005	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211188-004	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211188-005	AP	1	`4b0b4de00fa7…`

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
Sterile Water	STERILE WATER FOR INJECTION	Medefil, Inc.	99e99a50-82d5-aff6-e053-2a95a90a8c56	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211188 application number: ANDA211188 ndc (product): 64253-020

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64253-020	Sterile Water	Sterile Water for Injection	Medefil, Inc.	ANDA	Current
64253-020	Sterile Water	Sterile Water for Injection	Medefil, Inc.	ANDA	Current
64253-020	Sterile Water	Sterile Water for Injection	Medefil, Inc.	ANDA	Current