Home Applications 215833 Application 215833
Type NDA
Sponsor ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PLUVICTO LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN INJECTABLE;INJECTION 1000 MBQ/ML (27MCI/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N215833-001 PLUVICTO LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215833-001 10406240 2028-08-15 U-4169 Drug substance, Drug product 2022-04-20 N215833-001 10406240 2028-08-15 U-4593 Drug substance, Drug product 2022-04-20 N215833-001 10406240 2028-08-15 U-4594 Drug substance, Drug product 2022-04-20 N215833-001 11318121 2028-08-15 U-4169 Drug substance, Drug product 2022-05-31 N215833-001 11318121 2028-08-15 U-4593 Drug substance, Drug product 2022-05-31 N215833-001 11318121 2028-08-15 U-4594 Drug substance, Drug product 2022-05-31 N215833-001 11951190 2035-11-12 U-4169 2024-05-07 N215833-001 11951190 2035-11-12 U-4593 2024-05-07 N215833-001 11951190 2035-11-12 U-4594 2024-05-07 N215833-001 10398791 2036-03-23 Drug substance, Drug product 2022-04-20 N215833-001 12208102 2041-09-18 U-4169 2025-02-27 N215833-001 12208102 2041-09-18 U-4592 2025-02-27 N215833-001 12208102 2041-09-18 U-4593 2025-02-27
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215833-001 NCE 2027-03-23 N215833-001 I-965 2028-03-28 N215833-001 I-996 2029-07-31
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 2026-09-14 22:38:34 2026-08 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215833-001 PLUVICTO 27mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2022-03-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 124 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215833-001 10406240 2028-08-15 U-4169 Drug substance, Drug product 2022-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 10406240 2028-08-15 U-4594 Drug substance, Drug product 2022-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 10406240 2028-08-15 U-4593 Drug substance, Drug product 2022-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 11318121 2028-08-15 U-4169 Drug substance, Drug product 2022-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 11318121 2028-08-15 U-4594 Drug substance, Drug product 2022-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 11318121 2028-08-15 U-4593 Drug substance, Drug product 2022-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 11951190 2035-11-12 U-4169 2024-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 11951190 2035-11-12 U-4594 2024-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 11951190 2035-11-12 U-4593 2024-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 10398791 2036-03-23 Drug substance, Drug product 2022-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 12208102 2041-09-18 U-4169 2025-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 12208102 2041-09-18 U-4592 2025-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215833-001 12208102 2041-09-18 U-4593 2025-02-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215833-001 10406240 2028-08-15 U-4169 Drug substance, Drug product 2022-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215833-001 11318121 2028-08-15 U-4169 Drug substance, Drug product 2022-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215833-001 11951190 2035-11-12 U-4169 2024-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215833-001 10398791 2036-03-23 Drug substance, Drug product 2022-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215833-001 12208102 2041-09-18 U-4169 2025-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215833-001 10406240 2028-08-15 U-4169 Drug substance, Drug product 2022-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215833-001 11318121 2028-08-15 U-4169 Drug substance, Drug product 2022-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215833-001 10398791 2034-10-17 Drug substance, Drug product 2022-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215833-001 11951190 2035-11-12 U-4169 2024-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215833-001 12208102 2041-09-18 U-4169 2025-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215833-001 10406240 2028-08-15 U-4169 Drug substance, Drug product 2022-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215833-001 11318121 2028-08-15 U-4169 Drug substance, Drug product 2022-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215833-001 10398791 2034-10-17 Drug substance, Drug product 2022-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215833-001 11951190 2035-11-12 U-4169 2024-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215833-001 12208102 2041-09-18 U-4169 2025-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215833-001 10406240 2028-08-15 U-4169 Drug substance, Drug product 2022-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215833-001 11318121 2028-08-15 U-4169 Drug substance, Drug product 2022-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215833-001 10398791 2034-10-17 Drug substance, Drug product 2022-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215833-001 11951190 2035-11-12 U-4169 2024-05-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215833-001 12208102 2041-09-18 U-4169 2025-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215833-001 10406240 2028-08-15 U-3345 Drug substance, Drug product 2022-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215833-001 11318121 2028-08-15 U-3345 Drug substance, Drug product 2022-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215833-001 10398791 2034-10-17 Drug substance, Drug product 2022-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215833-001 11951190 2035-11-12 U-3345 2024-05-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215833-001 12208102 2041-09-18 U-3345 2025-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215833-001 10406240 2028-08-15 U-3345 Drug substance, Drug product 2022-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215833-001 11318121 2028-08-15 U-3345 Drug substance, Drug product 2022-05-31 b8a1b40f171c…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PLUVICTO LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN Novartis Pharmaceuticals Corporation 14908037-2892-4d98-a053-253ce35afb1a 2026-08-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 215833 application number: NDA215833
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69488-010 PLUVICTO lutetium Lu 177 vipivotide tetraxetan Advanced Accelerator Applications USA, Inc NDA Current 69488-010 PLUVICTO lutetium Lu 177 vipivotide tetraxetan Advanced Accelerator Applications USA, Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 85667 SUPPL 2026-04-10 85656 SUPPL 2026-04-09 81782 SUPPL 2026-03-02 81781 SUPPL 2026-03-02 81897 SUPPL 2025-04-09 81896 SUPPL 2025-04-09 70788 ORIG 2022-04-19 70596 ORIG 2022-03-24 70591 ORIG 2022-03-23