Home Applications 212155 Application 212155
Type NDA
Sponsor ZIONEXA US CORP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CERIANNA FLUOROESTRADIOL F18 INJECTABLE;INJECTION 148MBQ/ML TO 3700MBQ/ML(4MCI/ML TO 100MCI/ML) Yes No
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 N212155-001 CERIANNA FLUOROESTRADIOL F-18 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20
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.
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 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 a50c72e98297…
Observed Orange Book exclusivity 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current 72874-001 CERIANNA Fluoroestradiol F 18 Zionexa US Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 78412 SUPPL 2024-05-07 78409 SUPPL 2024-05-07 63646 ORIG 2020-06-19 63287 ORIG 2020-05-22 63258 ORIG 2020-05-22