Application 018664

Type: NDA
Sponsor: ANBEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IOSAT	POTASSIUM IODIDE	TABLET;ORAL	130MG	Yes	Yes
002	IOSAT	POTASSIUM IODIDE	TABLET;ORAL	65MG	Yes	No

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

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
N018664-001	IOSAT	POTASSIUM IODIDE	130MG	TABLET / ORAL		RLD, RS	1982-10-14
N018664-002	IOSAT	POTASSIUM IODIDE	65MG	TABLET / ORAL		RLD	2011-05-12

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018664-001	IOSAT	130MG	TABLET / ORAL	RLD, RS	1982-10-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018664-002	IOSAT	65MG	TABLET / ORAL	RLD	2011-05-12	`bb7c543d1eb4…`

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
IOSAT	POTASSIUM IODIDE	Anbex Inc.	ea98aef8-93b6-4fac-be35-eb17a1a04a92	2025-10-03	Warnings	Exact identifier application applno (NDA): 018664 application number: NDA018664 ndc (product): 51803-001
IOSAT	POTASSIUM IODIDE	Anbex Inc.	bab815ee-47ef-4c87-a60d-e0d7863ad871	2025-10-03	Warnings	Exact identifier application applno (NDA): 018664 application number: NDA018664 ndc (product): 51803-002

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
51803-001	IOSAT	Potassium Iodide	Anbex Inc.	NDA	Current
51803-001	IOSAT	Potassium Iodide	Anbex Inc.	NDA	Current
51803-001	IOSAT	Potassium Iodide	Anbex Inc.	NDA	Current
51803-001	IOSAT	Potassium Iodide	Anbex Inc.	NDA	Current
51803-001	IOSAT	Potassium Iodide	Anbex Inc.	NDA	Current
51803-002	IOSAT	Potassium Iodide	Anbex Inc.	NDA	Current
51803-002	IOSAT	Potassium Iodide	Anbex Inc.	NDA	Current
51803-002	IOSAT	Potassium Iodide	Anbex Inc.	NDA	Current
51803-002	IOSAT	Potassium Iodide	Anbex Inc.	NDA	Current
51803-002	IOSAT	Potassium Iodide	Anbex Inc.	NDA	Current