Application 007413

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROTAMINE SULFATE	PROTAMINE SULFATE	INJECTABLE;INJECTION	50MG/VIAL	No	No
002	PROTAMINE SULFATE	PROTAMINE SULFATE	INJECTABLE;INJECTION	250MG/VIAL	No	No

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

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
N007413-001	PROTAMINE SULFATE	PROTAMINE SULFATE	50MG/VIAL	POWDER / INTRAVENOUS		Approved before 1982
N007413-002	PROTAMINE SULFATE	PROTAMINE SULFATE	250MG/VIAL	POWDER / INTRAVENOUS			1984-08-02

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N007413-001	PROTAMINE SULFATE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N007413-002	PROTAMINE SULFATE	250MG/VIAL	INJECTABLE / INJECTION		1984-08-02	`3a93d1ddd44b…`

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	Name fallback brand name: Protamine Sulfate generic name: PROTAMINE SULFATE
Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	e1964129-33f4-4e4e-86e3-8e6a4e65bd83	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Protamine Sulfate generic name: PROTAMINE SULFATE
Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	7a31fc4c-579f-45cc-9559-39cfad9a57b3	2024-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Protamine Sulfate generic name: PROTAMINE SULFATE
PROTAMINE SULFATE	PROTAMINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	94d4f57f-940e-c0a8-e053-2a95a90ae3af	2024-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROTAMINE SULFATE generic name: PROTAMINE SULFATE
Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	8df0a819-9e1a-44ce-97a6-3ea82c867d44	2024-01-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Protamine Sulfate generic name: PROTAMINE SULFATE

Reported adverse events (FAERS/openFDA)#

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