Home Applications 022159 Application 022159
Type NDA
Sponsor SEPTODONT HOLDING Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORAVERSE PHENTOLAMINE MESYLATE INJECTABLE;INJECTION 0.4MG/1.7ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N022159-001 ORAVERSE PHENTOLAMINE MESYLATE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09
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 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 90 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022159-001 NPP 2019-03-18 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022159-001 NPP 2019-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022159-001 NPP 2019-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022159-001 NPP 2019-03-18 ea99ee380514…
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0362-0101 Oraverse Phentolamine Mesylate Septodont, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 29338 SUPPL 2016-03-23 17034 SUPPL 2016-03-22 21949 ORIG 2009-08-26 44688 ORIG 2008-07-17 6985 ORIG 2008-05-14 66983 SUPPL 1900-01-01 63540 ORIG 1900-01-01 51463 ORIG 1900-01-01 51462 ORIG 1900-01-01