Application 017922
- Type
- NDA
- Sponsor
- FERRING PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DDAVP | DESMOPRESSIN ACETATE | SOLUTION;NASAL | 0.01% | Yes | Yes |
| 002 | DDAVP | DESMOPRESSIN ACETATE | SPRAY, METERED;NASAL | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | DDAVP (NEEDS NO REFRIGERATION) | DESMOPRESSIN ACETATE | SPRAY, METERED;NASAL | 0.01MG/SPRAY | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017922-001 | DDAVP | DESMOPRESSIN ACETATE | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | ||
| N017922-002 | DDAVP | DESMOPRESSIN ACETATE | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | |
| N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | DESMOPRESSIN ACETATE | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017922-002 | DDAVP | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 1989-02-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017922-003 | DDAVP (NEEDS NO REFRIGERATION) | 0.01MG/SPRAY | SPRAY, METERED / NASAL | RLD | 1996-08-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017922-001 | DDAVP | 0.01% | SOLUTION / NASAL | RLD, Approved before 1982 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N017922-003 | AB | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | N017922-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N017922-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N017922-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N017922-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N017922-003 | AB | 1 | 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.
| 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 | DESMOPRESSIN ACETATE |
| Stimate | DESMOPRESSIN ACETATE | Ferring Pharmaceuticals Inc. | f5ada39c-20ed-4500-9dce-1e4ab642a358 | 2026-07-22 | Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Armas Pharmaceuticals Inc. | d87168b9-f103-4ba5-b0b3-0656d1c81da2 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Armas Pharmaceuticals Inc. | 673cd9ab-b714-49ee-9ce7-c99be605c30e | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | REMEDYREPACK INC. | f140926e-3201-4b8e-8207-14c560ddb55e | 2026-04-23 | Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Caplin Steriles Limited | 84dbb392-4535-4cbc-af60-75abb494f26e | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin acetate | DESMOPRESSIN ACETATE | Meitheal Pharmaceuticals Inc. | 2a2a6eba-c5bf-4ee4-bb18-c992ae59dce5 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Northwind Health Company, LLC | f306e2d4-781f-ff8f-e053-2a95a90ad15b | 2026-01-01 | Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | American Health Packaging | 0d447b48-3f4b-430e-9e68-d8b9401c002e | 2025-11-13 | Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Bryant Ranch Prepack | dc9b0dad-d265-4dff-8191-d936280d85a2 | 2025-11-07 | Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Nordic Pharma, Inc. | 29df0492-f7ef-47bb-aa67-4ef9e5c2846f | 2025-10-24 | Boxed warning, Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Nordic Pharma, Inc. | 10b29aa2-274e-4c29-bccd-424bd3761758 | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Apotex Corp. | 72aeef35-c102-b628-0219-9822651887eb | 2025-09-17 | Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | Apotex Corp. | 1ac423b8-27a6-4cef-4a82-c50bf81b4f49 | 2025-08-22 | Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Nordic Pharma, Inc. | 131fd4d8-48ca-4c1f-8165-848dc0a4d511 | 2025-07-23 | Boxed warning, Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Oceanside Pharmaceuticals | 8034989a-45f5-436b-8b1f-42108ee2a21a | 2025-06-19 | Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | UBI Pharma Inc. | b01c22dc-eecd-11b2-e053-2a95a90a529a | 2025-02-19 | Boxed warning, Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Bryant Ranch Prepack | 52133714-37d1-458d-9839-f0bd206711ea | 2025-01-31 | Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| Desmopressin Acetate | DESMOPRESSIN ACETATE | Nordic Pharma, Inc. | c01048e8-d28f-4085-9c37-3d5d48395a77 | 2024-12-06 | Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
| DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | UBI Pharma Inc. | b2fad59d-6176-4e09-9fbb-5cdd7f8f1568 | 2024-09-27 | Boxed warning, Warnings, Adverse reactions | DESMOPRESSIN ACETATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55566-2400 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2400 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2400 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2400 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2400 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2500 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2500 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2500 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2500 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2500 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 69918-501 | Desmopressin Acetate | Desmopressin Acetate | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 69918-501 | Desmopressin Acetate | Desmopressin Acetate | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 69918-501 | Desmopressin Acetate | Desmopressin Acetate | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 69918-501 | Desmopressin Acetate | Desmopressin Acetate | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |