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 44.

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022159-001	ORAVERSE	0.4MG/1.7ML	INJECTABLE / INJECTION	RLD, RS	2008-05-09	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022159-001	7229630	2023-06-20		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022159-001	7569230	2023-10-17	U-967		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022159-001	7575757	2025-04-21		Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022159-001	7229630	2023-06-20		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022159-001	7569230	2023-10-17	U-967		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022159-001	7575757	2025-04-21		Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022159-001	7229630	2023-06-20		Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022159-001	7569230	2023-10-17	U-967		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022159-001	7575757	2025-04-21		Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022159-001	6764678	2021-05-11	U-967		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022159-001	6872390	2021-05-11		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022159-001	7229630	2023-06-20		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022159-001	7569230	2023-10-17	U-967		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022159-001	7575757	2025-04-21		Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022159-001	7229630	2023-06-20		Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022159-001	7569230	2023-10-17	U-967		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022159-001	7575757	2025-04-21		Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022159-001	6764678	2021-05-11	U-967		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022159-001	6872390	2021-05-11		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022159-001	7229630	2023-06-20		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022159-001	7569230	2023-10-17	U-967		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022159-001	7575757	2025-04-21		Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022159-001	6764678	2021-05-11	U-967		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022159-001	6872390	2021-05-11		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022159-001	7229630	2023-06-20		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022159-001	7569230	2023-10-17	U-967		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022159-001	7575757	2025-04-21		Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022159-001	6764678	2021-05-11	U-967		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022159-001	6872390	2021-05-11		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022159-001	7229630	2023-06-20		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022159-001	7569230	2023-10-17	U-967		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022159-001	7575757	2025-04-21		Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022159-001	6764678	2021-05-11	U-967		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022159-001	6872390	2021-05-11		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022159-001	7229630	2023-06-20		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022159-001	7569230	2023-10-17	U-967		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022159-001	7575757	2025-04-21		Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022159-001	6764678	2021-05-11	U-967		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022159-001	6872390	2021-05-11		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022159-001	7229630	2023-06-20		Drug product	`c0c555d07b60…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oraverse	PHENTOLAMINE MESYLATE	Septodont, Inc.	4025cf98-ea87-4531-b0fc-6283c84f63f3	2018-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022159 application number: NDA022159 ndc (product): 0362-0101

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 · 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