Home Applications 020314 Application 020314
Type NDA
Sponsor CURIUM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OCTREOSCAN INDIUM IN-111 PENTETREOTIDE KIT INJECTABLE;INJECTION 3mCi/ML Yes 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 N020314-001 OCTREOSCAN INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION AP RLD, RS 1994-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020314-001 OCTREOSCAN 3mCi/ML INJECTABLE / INJECTION RLD, RS 1994-06-02 e64feba35796…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69945-050 OCTREOSCAN Indium In -111 Pentetreotide Curium US LLC NDA Current 69945-050 OCTREOSCAN Indium In -111 Pentetreotide Curium US LLC NDA Current 69945-050 OCTREOSCAN Indium In -111 Pentetreotide Curium US LLC NDA Current 69945-050 OCTREOSCAN Indium In -111 Pentetreotide Curium US LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 70147 SUPPL 2022-02-11 70136 SUPPL 2022-02-10 69778 SUPPL 2021-12-27 69755 SUPPL 2021-12-27