Application 089454

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROTAMINE SULFATE	PROTAMINE SULFATE	INJECTABLE;INJECTION	10MG/ML	No	Yes
002	PROTAMINE SULFATE	PROTAMINE SULFATE	SOLUTION;INTRAVENOUS	250MG/25ML (10MG/ML)	No	Yes

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
A089454-001	PROTAMINE SULFATE	PROTAMINE SULFATE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RS	1987-04-07
A089454-002	PROTAMINE SULFATE	PROTAMINE SULFATE	250MG/25ML (10MG/ML)	SOLUTION / INTRAVENOUS		RS	1987-04-07

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089454-001	PROTAMINE SULFATE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RS	1987-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089454-002	PROTAMINE SULFATE	250MG/25ML (10MG/ML)	SOLUTION / INTRAVENOUS	RS	1987-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089454-001	PROTAMINE SULFATE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RS	1987-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089454-002	PROTAMINE SULFATE	250MG/25ML (10MG/ML)	SOLUTION / INTRAVENOUS	RS	1987-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`f41ea6bd6efb…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	c76876da-b9a8-45d0-9278-7df3288d3a06	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089454 application number: ANDA089454
Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	e1964129-33f4-4e4e-86e3-8e6a4e65bd83	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089454 application number: ANDA089454 ndc (product): 63323-229
Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	7a31fc4c-579f-45cc-9559-39cfad9a57b3	2024-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089454 application number: ANDA089454 ndc (product): 63323-229
PROTAMINE SULFATE	PROTAMINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	94d4f57f-940e-c0a8-e053-2a95a90ae3af	2024-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089454 application number: ANDA089454 ndc (product): 51662-1414
Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	8df0a819-9e1a-44ce-97a6-3ea82c867d44	2024-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089454 application number: ANDA089454 ndc (product): 63323-229

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1414	PROTAMINE SULFATE	PROTAMINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1414	PROTAMINE SULFATE	PROTAMINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
63323-229	Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-229	Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-229	Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-229	Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-229	Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	ANDA	Current