Application 019228

Type: NDA
Sponsor: ABRAXIS PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MANGANESE SULFATE	MANGANESE SULFATE	INJECTABLE;INJECTION	EQ 0.1MG MANGANESE/ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019228-001	MANGANESE SULFATE	MANGANESE SULFATE	EQ 0.1MG MANGANESE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1987-05-05

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 · 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
2022-10-28 04:53 UTC	2022-10	N019228-001	MANGANESE SULFATE	EQ 0.1MG MANGANESE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019228-001	MANGANESE SULFATE	EQ 0.1MG MANGANESE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-05-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019228-001	MANGANESE SULFATE	EQ 0.1MG MANGANESE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-05-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019228-001	MANGANESE SULFATE	EQ 0.1MG MANGANESE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-05-05	`a50c72e98297…`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BM Manganese sulfate (Mang Sulf)	MANGANESE SULFATE	BM Private Limited	38043162-2a06-440e-e063-6394a90aa587	2025-12-02	Warnings	Name fallback generic name: MANGANESE SULFATE
Bestmade Natural Products Manganese Sulfate (Mang Sulf)	MANGANESE SULFATE	Bestmade Natural Products	2fad0266-2102-9c98-e063-6394a90a51ab	2025-05-26	Warnings	Name fallback generic name: MANGANESE SULFATE

Reported adverse events (FAERS/openFDA)#

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