Application 022517

Type: NDA
Sponsor: FERRING PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOCDURNA	DESMOPRESSIN ACETATE	TABLET;SUBLINGUAL	0.0277MG	Yes	No
002	NOCDURNA	DESMOPRESSIN ACETATE	TABLET;SUBLINGUAL	0.0553MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N022517-001	NOCDURNA	DESMOPRESSIN ACETATE	0.0277MG	TABLET / SUBLINGUAL		RLD	2018-06-21
N022517-002	NOCDURNA	DESMOPRESSIN ACETATE	0.0553MG	TABLET / SUBLINGUAL		RLD	2018-06-21

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022517-001	11020448	2029-05-21	U-2327	2021-06-17
N022517-001	11963995	2029-05-21	U-2327	2024-05-21
N022517-001	9974826	2030-04-13	U-2326	2018-07-19
N022517-002	10137167	2029-05-21	U-2327	2018-12-12
N022517-002	11963995	2029-05-21	U-2327	2024-05-21
N022517-002	9974826	2030-04-13	U-2327	2018-07-19

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 · 86 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	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD, RS	2018-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD, RS	2018-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD, RS	2018-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD, RS	2018-06-21	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 552 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022517-001	11020448	2029-05-21	U-2327	2021-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022517-001	11963995	2029-05-21	U-2327	2024-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022517-001	9974826	2030-04-13	U-2326	2018-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022517-002	10137167	2029-05-21	U-2327	2018-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022517-002	11963995	2029-05-21	U-2327	2024-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022517-002	9974826	2030-04-13	U-2327	2018-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022517-001	11020448	2029-05-21	U-2327	2021-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-001	11963995	2029-05-21	U-2327	2024-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-001	9974826	2030-04-13	U-2326	2018-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-002	10137167	2029-05-21	U-2327	2018-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-002	11963995	2029-05-21	U-2327	2024-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-002	9974826	2030-04-13	U-2327	2018-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022517-001	11020448	2029-05-21	U-2327	2021-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-001	11963995	2029-05-21	U-2327	2024-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-001	9974826	2030-04-13	U-2326	2018-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-002	10137167	2029-05-21	U-2327	2018-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-002	11963995	2029-05-21	U-2327	2024-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-002	9974826	2030-04-13	U-2327	2018-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-001	11020448	2029-05-21	U-2327	2021-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-001	11963995	2029-05-21	U-2327	2024-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-001	9974826	2030-04-13	U-2326	2018-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-002	10137167	2029-05-21	U-2327	2018-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-002	11963995	2029-05-21	U-2327	2024-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-002	9974826	2030-04-13	U-2327	2018-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022517-001	11020448	2029-05-21	U-2327	2021-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-001	11963995	2029-05-21	U-2327	2024-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-001	9974826	2030-04-13	U-2326	2018-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-002	10137167	2029-05-21	U-2327	2018-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-002	11963995	2029-05-21	U-2327	2024-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-002	9974826	2030-04-13	U-2327	2018-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-001	11020448	2029-05-21	U-2327	2021-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-001	11963995	2029-05-21	U-2327	2024-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-001	9974826	2030-04-13	U-2326	2018-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-002	10137167	2029-05-21	U-2327	2018-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-002	11963995	2029-05-21	U-2327	2024-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-002	9974826	2030-04-13	U-2327	2018-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-001	11020448	2029-05-21	U-2327	2021-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-001	11963995	2029-05-21	U-2327	2024-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-001	9974826	2030-04-13	U-2326	2018-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-002	10137167	2029-05-21	U-2327	2018-12-12	`b8a1b40f171c…`

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	N022517-001	NP	2021-06-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022517-002	NP	2021-06-21	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022517-001	NP	2021-06-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022517-002	NP	2021-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022517-001	NP	2021-06-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022517-002	NP	2021-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022517-001	NP	2021-06-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022517-002	NP	2021-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022517-001	NP	2021-06-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022517-002	NP	2021-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022517-001	NP	2021-06-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022517-002	NP	2021-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022517-001	NP	2021-06-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022517-002	NP	2021-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022517-001	NP	2021-06-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022517-002	NP	2021-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022517-001	NP	2021-06-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022517-002	NP	2021-06-21	`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 · 40 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	Avenacy, Inc.	c2e21331-4d54-4fa7-8f0d-31fe23a981aa	2024-01-15	Boxed warning, 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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54436-325	NOCDURNA	DESMOPRESSIN ACETATE	Antares Pharma, Inc.	NDA	Current
54436-325	NOCDURNA	DESMOPRESSIN ACETATE	Antares Pharma, Inc.	NDA	Current
54436-350	NOCDURNA	DESMOPRESSIN ACETATE	Antares Pharma, Inc.	NDA	Current
54436-350	NOCDURNA	DESMOPRESSIN ACETATE	Antares Pharma, Inc.	NDA	Current
55566-5050	NOCDURNA	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	NDA	Current
55566-5050	NOCDURNA	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	NDA	Current
55566-5050	NOCDURNA	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	NDA	Current
55566-5050	NOCDURNA	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	NDA	Current
55566-5070	NOCDURNA	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	NDA	Current
55566-5070	NOCDURNA	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	NDA	Current
55566-5070	NOCDURNA	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	NDA	Current
55566-5070	NOCDURNA	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54661	ORIG	2019-05-13
54660	ORIG	2018-06-21
54659	ORIG	2018-06-21
54658	ORIG	2018-06-21