Application 006460

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	PROTAMINE SULFATE	PROTAMINE SULFATE	INJECTABLE;INJECTION	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	PROTAMINE SULFATE	PROTAMINE SULFATE	SOLUTION;INTRAVENOUS	250MG/25ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No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
N006460-002	PROTAMINE SULFATE	PROTAMINE SULFATE	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD, Approved before 1982
N006460-003	PROTAMINE SULFATE	PROTAMINE SULFATE	250MG/25ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD, Approved before 1982

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 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N006460-002	PROTAMINE SULFATE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N006460-002	PROTAMINE SULFATE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N006460-002	PROTAMINE SULFATE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N006460-002	PROTAMINE SULFATE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N006460-002	PROTAMINE SULFATE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N006460-002	PROTAMINE SULFATE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N006460-002	PROTAMINE SULFATE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N006460-002	PROTAMINE SULFATE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N006460-002	PROTAMINE SULFATE	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N006460-003	PROTAMINE SULFATE	250MG/25ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD, Approved before 1982	`a50c72e98297…`

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.