Home Applications 017806 Application 017806
Type NDA
Sponsor LANTHEUS MEDCL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 THALLOUS CHLORIDE TL 201 THALLOUS CHLORIDE TL-201 INJECTABLE;INJECTION 1mCi/ML Yes Yes 002 THALLOUS CHLORIDE TL 201 THALLOUS CHLORIDE TL-201 INJECTABLE;INTRAVENOUS 2mCi/ML Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N017806-001 THALLOUS CHLORIDE TL 201 THALLOUS CHLORIDE TL-201 1mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 N017806-002 THALLOUS CHLORIDE TL 201 THALLOUS CHLORIDE TL-201 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 1998-10-09
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 2 of 3 · 88 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 2019-12-13 00:20 UTC 2019-12 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION RLD, Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION RLD, Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION RLD, Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION RLD, Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION RLD, Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N017806-001 THALLOUS CHLORIDE TL 201 1mCi/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N017806-002 THALLOUS CHLORIDE TL 201 2mCi/ML INJECTABLE / INTRAVENOUS RLD 1998-10-09 3a93d1ddd44b…
Observed Orange Book normalized TE history# 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 11994-427 Thallous Chloride Tl 201 THALLOUS CHLORIDE TL-201 Lantheus Medical Imaging, Inc. NDA Current 11994-427 Thallous Chloride Tl 201 THALLOUS CHLORIDE TL-201 Lantheus Medical Imaging, Inc. NDA Current 11994-427 Thallous Chloride Tl 201 THALLOUS CHLORIDE TL-201 Lantheus Medical Imaging, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 33348 SUPPL 2011-08-26 13902 SUPPL 2011-08-26