Application 209128

Type: NDA
Sponsor: ACELRX PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DSUVIA	SUFENTANIL CITRATE	TABLET;SUBLINGUAL	EQ 0.03MG BASE	Yes	Yes

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
N209128-001	DSUVIA	SUFENTANIL CITRATE	EQ 0.03MG BASE	TABLET / SUBLINGUAL		RLD	2018-11-02

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209128-001	10245228	2027-01-05	U-1351	Drug product	2019-04-19
N209128-001	10342762	2027-01-05		Drug product	2019-07-23
N209128-001	10507180	2027-01-05	U-1351	Drug product	2020-01-09
N209128-001	8226978	2027-01-05	U-1351	Drug product	2018-11-28
N209128-001	8231900	2027-01-05		Drug product	2018-11-28
N209128-001	8252328	2027-01-05		Drug product	2018-11-28
N209128-001	8252329	2027-01-05		Drug product	2018-11-28
N209128-001	8535714	2027-01-05	U-1351	Drug product	2018-11-28
N209128-001	8778393	2027-01-05	U-1351		2018-11-28
N209128-001	8778394	2027-01-05	U-1351		2018-11-28
N209128-001	8865211	2027-01-05	U-1351		2018-11-28
N209128-001	9320710	2027-01-05	U-1351		2018-11-28
N209128-001	9744129	2027-01-05		Drug product	2018-11-28
N209128-001	10896751	2030-03-16		Drug product	2021-02-02
N209128-001	11676691	2030-03-16		Drug product	2023-07-13
N209128-001	12033733	2030-03-16		Drug product	2024-07-31
N209128-001	8574189	2030-03-16		Drug product	2018-11-28
N209128-001	8202535	2030-10-22	U-1351		2018-11-28
N209128-001	8865743	2030-10-22	U-1351		2018-11-28
N209128-001	8945592	2031-07-29		Drug product	2018-11-28
N209128-001	11672738	2038-02-02		Drug product	2023-07-13

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 821 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	N209128-001	10245228	2027-01-05	U-1351	Drug product	2019-04-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	10342762	2027-01-05		Drug product	2019-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	10507180	2027-01-05	U-1351	Drug product	2020-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8226978	2027-01-05	U-1351	Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8231900	2027-01-05		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8252328	2027-01-05		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8252329	2027-01-05		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8535714	2027-01-05	U-1351	Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8778393	2027-01-05	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8778394	2027-01-05	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8865211	2027-01-05	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	9320710	2027-01-05	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	9744129	2027-01-05		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	10896751	2030-03-16		Drug product	2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	11676691	2030-03-16		Drug product	2023-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	12033733	2030-03-16		Drug product	2024-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8574189	2030-03-16		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8202535	2030-10-22	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8865743	2030-10-22	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8945592	2031-07-29		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	11672738	2038-02-02		Drug product	2023-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209128-001	10245228	2027-01-05	U-1351	Drug product	2019-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	10342762	2027-01-05		Drug product	2019-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	10507180	2027-01-05	U-1351	Drug product	2020-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8226978	2027-01-05	U-1351	Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8231900	2027-01-05		Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8252328	2027-01-05		Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8252329	2027-01-05		Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8535714	2027-01-05	U-1351	Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8778393	2027-01-05	U-1351		2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8778394	2027-01-05	U-1351		2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8865211	2027-01-05	U-1351		2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	9320710	2027-01-05	U-1351		2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	9744129	2027-01-05		Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	10896751	2030-03-16		Drug product	2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	11676691	2030-03-16		Drug product	2023-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	12033733	2030-03-16		Drug product	2024-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8574189	2030-03-16		Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8202535	2030-10-22	U-1351		2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8865743	2030-10-22	U-1351		2018-11-28	`caaa826d4ba7…`

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	N209128-001	NP	2021-11-02	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209128-001	NP	2021-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209128-001	NP	2021-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209128-001	NP	2021-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209128-001	NP	2021-11-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209128-001	NP	2021-11-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209128-001	NP	2021-11-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209128-001	NP	2021-11-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209128-001	NP	2021-11-02	`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
Sufentanil Citrate	SUFENTANIL CITRATE	Hospira, Inc.	20293943-46ff-4345-1aa4-929b4e017a25	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SUFENTANIL CITRATE

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
61621-430	Dsuvia	Sufentanil	AcelRx Pharmaceuticals, Inc	NDA	Current
61621-430	Dsuvia	Sufentanil	AcelRx Pharmaceuticals, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84652	SUPPL	2026-01-06
84582	SUPPL	2025-12-29
77080	SUPPL	2023-12-19
76972	SUPPL	2023-12-18
76364	ORIG	2023-11-06
70800	SUPPL	2022-04-22
60501	SUPPL	2019-10-09
60468	SUPPL	2019-10-09
57563	ORIG	2019-02-13
56285	ORIG	2018-11-06
56251	ORIG	2018-11-02