Application 076703

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	DESMOPRESSIN ACETATE	SPRAY, METERED;NASAL	0.01MG/SPRAY	No	No

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
A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	DESMOPRESSIN ACETATE	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076703-001	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076703-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076703-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076703-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076703-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076703-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076703-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076703-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076703-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076703-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076703-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076703-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076703-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076703-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076703-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076703-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076703-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076703-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076703-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076703-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076703-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076703-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076703-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076703-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076703-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076703-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076703-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076703-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076703-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076703-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076703-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076703-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076703-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076703-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076703-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076703-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076703-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076703-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076703-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076703-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076703-001	AB	1	`f41ea6bd6efb…`

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 2 · 40 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	2026-08-27	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	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
Desmopressin Acetate	DESMOPRESSIN ACETATE	Aurobindo Pharma Limited	24866ad0-94db-46a2-96c0-b362acd0271a	2024-03-25	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	XGen Pharmaceuticals DJB, Inc.	1052a869-b64d-655d-e063-6294a90ad0e2	2024-03-22	Boxed warning, 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-0815	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	Apotex Corp.	ANDA	Current
60505-0815	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	Apotex Corp.	ANDA	Current
60505-0815	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	Apotex Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22582	ORIG	2007-10-11
8952	ORIG	2005-01-27