Application 214597

Type: ANDA
Sponsor: NIVAGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZINC SULFATE	ZINC SULFATE	SOLUTION;INTRAVENOUS	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	No	No
002	ZINC SULFATE	ZINC SULFATE	SOLUTION;INTRAVENOUS	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	No	No
003	ZINC SULFATE	ZINC SULFATE	SOLUTION;INTRAVENOUS	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214597-001	ZINC SULFATE	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05
A214597-002	ZINC SULFATE	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05
A214597-003	ZINC SULFATE	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214597-001	AP
A214597-002	AP
A214597-003	AP

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 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214597-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214597-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214597-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214597-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214597-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214597-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214597-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214597-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214597-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214597-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214597-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214597-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214597-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214597-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214597-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214597-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214597-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214597-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214597-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214597-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214597-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214597-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214597-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214597-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214597-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214597-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214597-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214597-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214597-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214597-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214597-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214597-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214597-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214597-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214597-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214597-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214597-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214597-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214597-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214597-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214597-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214597-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214597-001	AP	1	`301d65b070ca…`

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.