Application 201656

Type: NDA
Sponsor: ALYVANT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOCTIVA	DESMOPRESSIN ACETATE	SPRAY, METERED;NASAL	0.00083MG/SPRAY	Yes	No
002	NOCTIVA	DESMOPRESSIN ACETATE	SPRAY, METERED;NASAL	0.00166MG/SPRAY	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N201656-001	NOCTIVA	DESMOPRESSIN ACETATE	0.00083MG/SPRAY	SPRAY, METERED / NASAL		RLD	2017-03-03
N201656-002	NOCTIVA	DESMOPRESSIN ACETATE	0.00166MG/SPRAY	SPRAY, METERED / NASAL		RLD	2017-03-03

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201656-001	11419914	2030-06-15	U-3431		2022-09-20
N201656-001	12090190	2030-06-15	U-4003	Drug product	2024-10-11
N201656-001	9539302	2030-06-15		Drug product	2017-03-31
N201656-002	11419914	2030-06-15	U-3431		2022-09-20
N201656-002	12090190	2030-06-15	U-4003	Drug product	2024-10-11
N201656-002	9539302	2030-06-15		Drug product	2017-03-31

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.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201656-001	NOCTIVA	0.00083MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201656-002	NOCTIVA	0.00166MG/SPRAY	SPRAY, METERED / NASAL	RLD	2017-03-03	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 257 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N201656-001	11419914	2030-06-15	U-3431		2022-09-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201656-001	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201656-001	9539302	2030-06-15		Drug product	2017-03-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201656-002	11419914	2030-06-15	U-3431		2022-09-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201656-002	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201656-002	9539302	2030-06-15		Drug product	2017-03-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N201656-001	11419914	2030-06-15	U-3431		2022-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201656-001	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201656-001	9539302	2030-06-15		Drug product	2017-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201656-002	11419914	2030-06-15	U-3431		2022-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201656-002	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201656-002	9539302	2030-06-15		Drug product	2017-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201656-001	11419914	2030-06-15	U-3431		2022-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201656-001	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201656-001	9539302	2030-06-15		Drug product	2017-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201656-002	11419914	2030-06-15	U-3431		2022-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201656-002	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201656-002	9539302	2030-06-15		Drug product	2017-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201656-001	11419914	2030-06-15	U-3431		2022-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201656-001	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201656-001	9539302	2030-06-15		Drug product	2017-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201656-002	11419914	2030-06-15	U-3431		2022-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201656-002	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201656-002	9539302	2030-06-15		Drug product	2017-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201656-001	11419914	2030-06-15	U-3431		2022-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201656-001	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201656-001	9539302	2030-06-15		Drug product	2017-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201656-002	11419914	2030-06-15	U-3431		2022-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201656-002	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201656-002	9539302	2030-06-15		Drug product	2017-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201656-001	11419914	2030-06-15	U-3431		2022-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201656-001	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201656-001	9539302	2030-06-15		Drug product	2017-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201656-002	11419914	2030-06-15	U-3431		2022-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201656-002	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201656-002	9539302	2030-06-15		Drug product	2017-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201656-001	11419914	2030-06-15	U-3431		2022-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201656-001	12090190	2030-06-15	U-4003	Drug product	2024-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201656-001	9539302	2030-06-15		Drug product	2017-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201656-002	11419914	2030-06-15	U-3431		2022-09-20	`fd3edfee7708…`

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	N201656-001	NP	2020-03-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201656-002	NP	2020-03-03	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N201656-001	NP	2020-03-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201656-002	NP	2020-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201656-001	NP	2020-03-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201656-002	NP	2020-03-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201656-001	NP	2020-03-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201656-002	NP	2020-03-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201656-001	NP	2020-03-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N201656-002	NP	2020-03-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201656-001	NP	2020-03-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N201656-002	NP	2020-03-03	`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 2 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desmopressin Acetate	DESMOPRESSIN ACETATE	KVK-TECH, INC.	9fba5e90-f541-4588-a5e9-b56198f17e87	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Fresenius Kabi USA, LLC	9725ba8e-ac0f-4655-bb98-9ea926142815	2023-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Fresenius Kabi USA, LLC	0d96944d-736d-4b56-b726-d21eacd8bc85	2023-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	BluePoint Laboratories	c04357fd-478a-4909-b098-ae6710be071c	2023-08-04	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Sun Pharmaceutical Industries Limited	539d7da2-72b8-45f9-836c-4e3351dd488e	2023-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Sun Pharmaceutical Industries Limited	cdec2cc2-4fd9-474e-884f-d0599e40948f	2023-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Gland Pharma Limited	848d5173-ce26-46bf-b180-7ed13f0233b5	2023-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Gland Pharma Limited	7f4e5a22-85e8-4c28-9ebf-d6ebc75ad653	2022-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
desmopressin acetate	DESMOPRESSIN ACETATE	Sagent Pharmaceuticals	40752c75-d09b-4013-9024-442048145b63	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
desmopressin acetate	DESMOPRESSIN ACETATE	Sagent Pharmaceuticals	39381e84-0e87-4731-b725-f0fdf4b5ca2b	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
DDAVP	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	651f6fee-a2c7-431b-8d5d-58b156c72244	2022-09-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Sun Pharmaceutical Industries, Inc.	9fd48eec-aa24-4888-b99f-d409ada958a7	2022-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Dr. Reddy's Laboratories Inc.	60dd8694-58d8-d88e-26f2-f28baa53787e	2022-07-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	e87b6cfd-5677-4398-883d-7ced5dd678ef	2022-03-30	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Bauch & Lomb Incorporated	8ca799f1-7029-4527-9ab4-7512504bb8e2	2021-09-01	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
DDAVP	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	6d55baa9-2b62-469c-93ae-3909ab249332	2021-02-03	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
desmopressin acetate	DESMOPRESSIN ACETATE	Sun Pharmaceutical Industries, Inc.	2dc2cec8-6953-4a33-9356-11534fba1fb8	2020-01-23	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	Dr.Reddys' Laboratories Inc	15179e0c-f677-307f-d1e1-5910de4c212f	2019-11-30	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Glenmark Pharmaceuticals Inc.,USA	7a26b415-77cd-4b2f-9c76-fa52d2eb6be6	2019-06-28	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71758-106	Noctiva	desmopressin acetate	Avadel Specialty Pharmaceuticals, LLC	NDA	Current
71758-106	Noctiva	desmopressin acetate	Avadel Specialty Pharmaceuticals, LLC	NDA	Current
71758-107	Noctiva	desmopressin acetate	Avadel Specialty Pharmaceuticals, LLC	NDA	Current
71758-107	Noctiva	desmopressin acetate	Avadel Specialty Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54231	ORIG	2018-05-17
47476	ORIG	2017-03-07
47455	ORIG	2017-03-03
47450	ORIG	2017-03-03
47448	ORIG	2017-03-03