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 42.

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
2022-03-09 01:35 UTC	2022-03	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD, RS	2018-06-21	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 546 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-002	11963995	2029-05-21	U-2327		2024-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-002	9974826	2030-04-13	U-2327		2018-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-001	7560429	2024-02-02	U-2326	Drug product	2018-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-001	11020448	2029-05-21	U-2327		2021-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-001	11963995	2029-05-21	U-2327		2024-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-001	9974826	2030-04-13	U-2326		2018-07-19	`03ed91905a0d…`

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 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desmopressin Acetate	DESMOPRESSIN ACETATE	The J. Molner Company LLC	52680415-52a0-61c2-e063-6294a90ae27e	2026-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Stimate	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	f5ada39c-20ed-4500-9dce-1e4ab642a358	2026-07-22	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Armas Pharmaceuticals Inc.	d87168b9-f103-4ba5-b0b3-0656d1c81da2	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Armas Pharmaceuticals Inc.	673cd9ab-b714-49ee-9ce7-c99be605c30e	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	REMEDYREPACK INC.	f140926e-3201-4b8e-8207-14c560ddb55e	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Caplin Steriles Limited	84dbb392-4535-4cbc-af60-75abb494f26e	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin acetate	DESMOPRESSIN ACETATE	Meitheal Pharmaceuticals Inc.	2a2a6eba-c5bf-4ee4-bb18-c992ae59dce5	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Northwind Health Company, LLC	f306e2d4-781f-ff8f-e053-2a95a90ad15b	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	American Health Packaging	0d447b48-3f4b-430e-9e68-d8b9401c002e	2025-11-13	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Bryant Ranch Prepack	dc9b0dad-d265-4dff-8191-d936280d85a2	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Nordic Pharma, Inc.	29df0492-f7ef-47bb-aa67-4ef9e5c2846f	2025-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Nordic Pharma, Inc.	10b29aa2-274e-4c29-bccd-424bd3761758	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Apotex Corp.	72aeef35-c102-b628-0219-9822651887eb	2025-09-17	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	Apotex Corp.	1ac423b8-27a6-4cef-4a82-c50bf81b4f49	2025-08-22	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Nordic Pharma, Inc.	131fd4d8-48ca-4c1f-8165-848dc0a4d511	2025-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Oceanside Pharmaceuticals	8034989a-45f5-436b-8b1f-42108ee2a21a	2025-06-19	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	UBI Pharma Inc.	b01c22dc-eecd-11b2-e053-2a95a90a529a	2025-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Bryant Ranch Prepack	52133714-37d1-458d-9839-f0bd206711ea	2025-01-31	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Nordic Pharma, Inc.	c01048e8-d28f-4085-9c37-3d5d48395a77	2024-12-06	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	UBI Pharma Inc.	b2fad59d-6176-4e09-9fbb-5cdd7f8f1568	2024-09-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE

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