Application 077218

Type: ANDA
Sponsor: ARCO PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THYROSHIELD	POTASSIUM IODIDE	SOLUTION;ORAL	65MG/ML	No	Yes

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

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
A077218-001	THYROSHIELD	POTASSIUM IODIDE	65MG/ML	SOLUTION / ORAL			2005-01-12

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 2 · 42 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	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL	RS	2005-01-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL	RS	2005-01-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL	RS	2005-01-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL	RS	2005-01-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL	RS	2005-01-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL	RS	2005-01-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL	RS	2005-01-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL	RS	2005-01-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077218-001	THYROSHIELD	65MG/ML	SOLUTION / ORAL		2005-01-12	`e64feba35796…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM IODIDE	POTASSIUM IODIDE	Mission Pharmacal Company	d9e02a48-8129-9076-78b2-db01750bd220	2026-01-07	Warnings	Name fallback generic name: POTASSIUM IODIDE
ThyroSafe	POTASSIUM IODIDE	BTG International Inc.	47762f8f-30e2-445d-aaa1-e04479f8dd5b	2025-12-17	Boxed warning, Warnings	Name fallback generic name: POTASSIUM IODIDE
KALI IODATUM 1X	POTASSIUM IODIDE	Natural Creations, Inc.	15eb7796-9787-454d-91a9-066b1dec9fd0	2025-12-16	Warnings	Name fallback generic name: POTASSIUM IODIDE
IOSAT	POTASSIUM IODIDE	Anbex Inc.	ea98aef8-93b6-4fac-be35-eb17a1a04a92	2025-10-03	Warnings	Name fallback generic name: POTASSIUM IODIDE
IOSAT	POTASSIUM IODIDE	Anbex Inc.	bab815ee-47ef-4c87-a60d-e0d7863ad871	2025-10-03	Warnings	Name fallback generic name: POTASSIUM IODIDE
SSKI	POTASSIUM IODIDE	Avondale Pharmaceuticals, LLC	ca1d3449-ea29-49a4-8863-365ec95f1553	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM IODIDE
SSKI	POTASSIUM IODIDE	ATLANTIC BIOLOGICALS CORP.	664e6cd9-6a3c-49ef-a7b2-d09f0338b549	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM IODIDE
Thyrosafe	POTASSIUM IODIDE	BTG International Inc	30387dc3-da14-1964-e063-6394a90afa4e	2025-03-13	Boxed warning, Warnings	Name fallback generic name: POTASSIUM IODIDE
POTASSIUM IODIDE	POTASSIUM IODIDE	Bryant Ranch Prepack	90cf3abb-c6d4-4004-8ae2-f528260a72f4	2024-11-11	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM IODIDE
Kali iodatum	POTASSIUM IODIDE	Boiron	8607ac12-58c2-6c3e-e053-2991aa0a5335	2023-11-13		Name fallback generic name: POTASSIUM IODIDE
Kali iodatum	POTASSIUM IODIDE	Boiron	86077d8a-c47c-9ea5-e053-2991aa0a3ae8	2023-11-13		Name fallback generic name: POTASSIUM IODIDE
Kali iodatum	POTASSIUM IODIDE	Boiron	0725b880-7bd2-11e6-bb67-424c58303031	2023-11-13		Name fallback generic name: POTASSIUM IODIDE
Kali iodatum	POTASSIUM IODIDE	Boiron	86075ed7-03be-0ded-e053-2a91aa0a2d84	2023-11-13		Name fallback generic name: POTASSIUM IODIDE
Kali iodatum	POTASSIUM IODIDE	Boiron	86080b3d-28c4-ed4a-e053-2a91aa0a51dc	2023-11-13		Name fallback generic name: POTASSIUM IODIDE
Kali iodatum	POTASSIUM IODIDE	Boiron	8607a7e8-c73f-5986-e053-2991aa0afb8a	2023-11-13		Name fallback generic name: POTASSIUM IODIDE
Kali iodatum	POTASSIUM IODIDE	Boiron	8607f5b5-fb02-79a1-e053-2991aa0a44a6	2023-08-29		Name fallback generic name: POTASSIUM IODIDE
POTASSIUM IODIDE	POTASSIUM IODIDE	Nivagen Pharmaceuticals, Inc.	b0bf9487-45d0-4fbc-a8dd-90f505355d14	2023-02-22	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM IODIDE
Kali iodatum	POTASSIUM IODIDE	Boiron	8607b598-935f-1581-e053-2991aa0afb11	2023-02-20		Name fallback generic name: POTASSIUM IODIDE
Kali iodatum	POTASSIUM IODIDE	Boiron	8607f32d-1e5c-13c6-e053-2991aa0a2943	2023-02-20		Name fallback generic name: POTASSIUM IODIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0256-0210	ThyroShield	Potassium Iodide	Fleming & Company, Pharmaceuticals	ANDA	Current
59465-210	ThyroShield	Potassium Iodide	Arco Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9019	ORIG	2005-01-13