Application 091374

Type: ANDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	INJECTABLE;INJECTION	0.004MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091374-001	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION			2019-02-14

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION		2019-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091374-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP	2019-02-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091374-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091374-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091374-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091374-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091374-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091374-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091374-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091374-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091374-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091374-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091374-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091374-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091374-001	AP	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091374-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091374-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091374-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091374-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091374-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091374-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091374-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091374-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091374-001	AP	1	`cb3db0bc1861…`

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 brand name: Desmopressin Acetate 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 brand name: Desmopressin Acetate 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 brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	REMEDYREPACK INC.	f140926e-3201-4b8e-8207-14c560ddb55e	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate 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 brand name: Desmopressin Acetate 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 brand name: Desmopressin acetate 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 brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	American Health Packaging	0d447b48-3f4b-430e-9e68-d8b9401c002e	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Bryant Ranch Prepack	dc9b0dad-d265-4dff-8191-d936280d85a2	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate 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 brand name: Desmopressin Acetate 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 brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Apotex Corp.	72aeef35-c102-b628-0219-9822651887eb	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	Apotex Corp.	1ac423b8-27a6-4cef-4a82-c50bf81b4f49	2025-08-22	Warnings, Adverse reactions	Name fallback brand name: DESMOPRESSIN ACETATE 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 brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Oceanside Pharmaceuticals	8034989a-45f5-436b-8b1f-42108ee2a21a	2025-06-19	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate 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 brand name: DESMOPRESSIN ACETATE generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Bryant Ranch Prepack	52133714-37d1-458d-9839-f0bd206711ea	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Nordic Pharma, Inc.	c01048e8-d28f-4085-9c37-3d5d48395a77	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate 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 brand name: DESMOPRESSIN ACETATE generic name: DESMOPRESSIN ACETATE

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
0517-4310	Desmopressin Acetate	Desmopressin Acetate	American Regent, Inc.	ANDA	Current