Application 209377

Type: NDA
Sponsor: AM REGENT

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
N209377-001	ZINC SULFATE	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18
N209377-002	ZINC SULFATE	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18
N209377-003	ZINC SULFATE	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N209377-001	AP
N209377-002	AP
N209377-003	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 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 85 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N209377-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209377-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209377-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209377-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209377-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209377-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209377-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209377-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209377-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209377-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209377-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209377-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209377-001	AP	1	`1e350fbaab3a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zinc Sulfate	ZINC SULFATE	American Regent, Inc.	4b528c88-07a0-4dce-84c6-ccd32555bbff	2020-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209377 application number: NDA209377 ndc (product): 0517-6101 ndc (product): 0517-8005 ndc (product): 0517-6103

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-6101	Zinc Sulfate	Zinc Sulfate	American Regent, Inc.	NDA	Current
0517-6101	Zinc Sulfate	Zinc Sulfate	American Regent, Inc.	NDA	Current
0517-6103	Zinc Sulfate	Zinc Sulfate	American Regent, Inc.	NDA	Current
0517-6103	Zinc Sulfate	Zinc Sulfate	American Regent, Inc.	NDA	Current
0517-6103	Zinc Sulfate	Zinc Sulfate	American Regent, Inc.	NDA	Current
0517-6103	Zinc Sulfate	Zinc Sulfate	American Regent, Inc.	NDA	Current
0517-8005	Zinc Sulfate	Zinc Sulfate	American Regent, Inc.	NDA	Current
0517-8005	Zinc Sulfate	Zinc Sulfate	American Regent, Inc.	NDA	Current
0517-8005	Zinc Sulfate	Zinc Sulfate	American Regent, Inc.	NDA	Current
0517-8005	Zinc Sulfate	Zinc Sulfate	American Regent, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65126	SUPPL	2020-11-02
65081	SUPPL	2020-10-30
60164	ORIG	2019-09-30
59387	ORIG	2019-07-19
59377	ORIG	2019-07-19
63286	ORIG	1900-01-01
63267	ORIG	1900-01-01