Application 214805

Type: ANDA
Sponsor: MILLA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM ACETATE	SODIUM ACETATE	INJECTABLE;INJECTION	2MEQ/ML	No	No
002	SODIUM ACETATE	SODIUM ACETATE	SOLUTION;INTRAVENOUS	400MEQ/100ML (4MEQ/ML)	No	No
003	SODIUM ACETATE	SODIUM ACETATE	SOLUTION;INTRAVENOUS	200MEQ/100ML (2MEQ/ML)	No	No
004	SODIUM ACETATE	SODIUM ACETATE	SOLUTION;INTRAVENOUS	40MEQ/20ML (2MEQ/ML)	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214805-001	SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04
A214805-002	SODIUM ACETATE	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25
A214805-003	SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04
A214805-004	SODIUM ACETATE	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214805-001	AP
A214805-002	AP
A214805-003	AP
A214805-004	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 · 83 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	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 83 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	A214805-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214805-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214805-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-004	AP	1	`d06236e962d9…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214805-001	CGT	2022-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214805-001	CGT	2022-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214805-001	CGT	2022-01-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214805-001	CGT	2022-01-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214805-001	CGT	2022-01-03	`782e0a99824c…`
2023-01-26 05:58 UTC	2023-01	A214805-001	CGT	2022-01-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214805-001	CGT	2022-01-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214805-001	CGT	2022-01-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214805-001	CGT	2022-01-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214805-001	CGT	2022-01-03	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Acetate	SODIUM ACETATE	MILLA PHARMACEUTICALS INC.	1ea1466d-a492-4056-e063-6394a90a80bf	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214805 application number: ANDA214805
Sodium Acetate	SODIUM ACETATE	MILLA PHARMACEUTICALS INC.	1ea04916-78e5-4651-e063-6394a90ac4be	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214805 application number: ANDA214805

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69784-230	SODIUM ACETATE	SODIUM ACETATE	Woodward Pharma Services LLC	ANDA	Current
69784-230	SODIUM ACETATE	SODIUM ACETATE	Woodward Pharma Services LLC	ANDA	Current
69784-231	SODIUM ACETATE	SODIUM ACETATE	Woodward Pharma Services LLC	ANDA	Current
69784-231	SODIUM ACETATE	SODIUM ACETATE	Woodward Pharma Services LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67815	ORIG	2021-06-15