Application 019229

Type: NDA
Sponsor: ABRAXIS PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ZINC SULFATE	ZINC SULFATE	INJECTABLE;INJECTION	EQ 1MG ZINC/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
N019229-002	ZINC SULFATE	ZINC SULFATE	EQ 1MG ZINC/ML	INJECTABLE / INJECTION			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	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N019229-002	ZINC SULFATE	EQ 1MG ZINC/ML	INJECTABLE / INJECTION	1987-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019229-002	ZINC SULFATE	EQ 1MG ZINC/ML	INJECTABLE / INJECTION	1987-05-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019229-002	ZINC SULFATE	EQ 1MG ZINC/ML	INJECTABLE / INJECTION	1987-05-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019229-002	ZINC SULFATE	EQ 1MG ZINC/ML	INJECTABLE / INJECTION	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZINC SULFATE	ZINC SULFATE	Camber Pharmaceuticals, Inc.	49698d00-f44b-4b1f-ae34-6b9067911757	2026-03-04	Warnings, Adverse reactions	Name fallback brand name: ZINC SULFATE generic name: ZINC SULFATE
Zinc Sulfate	ZINC SULFATE	Piramal Critical Care Inc.	dfa8a859-c285-17a3-e053-2a95a90a9343	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Zinc Sulfate generic name: ZINC SULFATE
Zinc Sulfate	ZINC SULFATE	Piramal Critical Care Inc.	0b6078d9-624c-e162-e063-6394a90a147d	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Zinc Sulfate generic name: ZINC SULFATE
zinc sulfate	ZINC SULFATE INJECTION,	Zydus Pharmaceuticals USA Inc.	95aa8437-10bc-4205-939f-d21d8fa52a00	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: zinc sulfate
Zinc sulfate	ZINC SULFATE	Somerset Therapeutics, LLC	c9d45d0e-a165-4112-81f9-c0e455572ecf	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Zinc sulfate generic name: ZINC SULFATE
Zinc Sulfate	ZINC SULFATE	Gland Pharma Limited	8f354f0a-4e10-4e4e-b86c-49d97cbd631d	2023-09-07	Warnings, Adverse reactions	Name fallback brand name: Zinc Sulfate generic name: ZINC SULFATE
zinc sulfate	ZINC SULFATE	Zydus Lifesciences Limited	74d8d07b-cfd9-4262-b689-fea12673bbd1	2023-08-31		Name fallback brand name: zinc sulfate generic name: ZINC SULFATE
Zinc Sulfate	ZINC SULFATE	Fresenius Kabi USA, LLC	37d54dcd-b720-4168-bfb2-c8f381466aac	2023-01-04	Warnings, Adverse reactions	Name fallback brand name: Zinc Sulfate generic name: ZINC SULFATE
Zinc Sulfate	ZINC SULFATE	American Regent, Inc.	4b528c88-07a0-4dce-84c6-ccd32555bbff	2020-10-01	Warnings, Adverse reactions	Name fallback brand name: Zinc Sulfate generic name: ZINC SULFATE

Reported adverse events (FAERS/openFDA)#

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