Home Applications 017630 Application 017630
Type NDA
Sponsor GE HEALTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SODIUM IODIDE I 123 SODIUM IODIDE I-123 CAPSULE;ORAL 100uCi No No 002 SODIUM IODIDE I 123 SODIUM IODIDE I-123 SOLUTION;ORAL 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 003 SODIUM IODIDE I 123 SODIUM IODIDE I-123 CAPSULE;ORAL 200uCi No No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 N017630-001 SODIUM IODIDE I 123 SODIUM IODIDE I-123 100uCi CAPSULE / ORAL Approved before 1982 N017630-002 SODIUM IODIDE I 123 SODIUM IODIDE I-123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 N017630-003 SODIUM IODIDE I 123 SODIUM IODIDE I-123 200uCi CAPSULE / ORAL 1993-01-08
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 · 112 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 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017630-002 SODIUM IODIDE I 123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017630-003 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL 1993-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017630-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL Approved before 1982 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 · 2 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 13871 SUPPL 2005-06-21