FDA.reportPublic FDA data

Application 017922

Type
NDA
Sponsor
FERRING PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DDAVPDESMOPRESSIN ACETATESOLUTION;NASAL0.01%YesYes
002DDAVPDESMOPRESSIN ACETATESPRAY, METERED;NASAL0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003DDAVP (NEEDS NO REFRIGERATION)DESMOPRESSIN ACETATESPRAY, METERED;NASAL0.01MG/SPRAYYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017922-001DDAVPDESMOPRESSIN ACETATE0.01%SOLUTION / NASALRLD, Approved before 1982
N017922-002DDAVPDESMOPRESSIN ACETATE0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1989-02-06
N017922-003DDAVP (NEEDS NO REFRIGERATION)DESMOPRESSIN ACETATE0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1996-08-07

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.

Product history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017922-001DDAVP0.01%SOLUTION / NASALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017922-002DDAVP0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1989-02-06f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017922-003DDAVP (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALRLD1996-08-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017922-001DDAVP0.01%SOLUTION / NASALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N017922-002DDAVP0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1989-02-06e64feba35796…
2022-09-29 23:25 UTC2022-09N017922-003DDAVP (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALRLD1996-08-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017922-001DDAVP0.01%SOLUTION / NASALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017922-002DDAVP0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1989-02-06cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017922-003DDAVP (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALRLD1996-08-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017922-001DDAVP0.01%SOLUTION / NASALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017922-002DDAVP0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1989-02-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017922-003DDAVP (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALRLD1996-08-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N017922-003AB174a2ff9319b5…
2020-11-12 02:37 UTC2020-11N017922-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017922-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017922-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017922-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N017922-003AB1ea99ee380514…

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 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desmopressin AcetateDESMOPRESSIN ACETATEThe J. Molner Company LLC52680415-52a0-61c2-e063-6294a90ae27e2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
StimateDESMOPRESSIN ACETATEFerring Pharmaceuticals Inc.f5ada39c-20ed-4500-9dce-1e4ab642a3582026-07-22Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATEArmas Pharmaceuticals Inc.d87168b9-f103-4ba5-b0b3-0656d1c81da22026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATEArmas Pharmaceuticals Inc.673cd9ab-b714-49ee-9ce7-c99be605c30e2026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATEREMEDYREPACK INC.f140926e-3201-4b8e-8207-14c560ddb55e2026-04-23Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATECaplin Steriles Limited84dbb392-4535-4cbc-af60-75abb494f26e2026-03-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin acetateDESMOPRESSIN ACETATEMeitheal Pharmaceuticals Inc.2a2a6eba-c5bf-4ee4-bb18-c992ae59dce52026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATENorthwind Health Company, LLCf306e2d4-781f-ff8f-e053-2a95a90ad15b2026-01-01Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATEAmerican Health Packaging0d447b48-3f4b-430e-9e68-d8b9401c002e2025-11-13Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATEBryant Ranch Prepackdc9b0dad-d265-4dff-8191-d936280d85a22025-11-07Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATENordic Pharma, Inc.29df0492-f7ef-47bb-aa67-4ef9e5c2846f2025-10-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATENordic Pharma, Inc.10b29aa2-274e-4c29-bccd-424bd37617582025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATENordic Pharma, Inc.131fd4d8-48ca-4c1f-8165-848dc0a4d5112025-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATEOceanside Pharmaceuticals8034989a-45f5-436b-8b1f-42108ee2a21a2025-06-19Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATEDESMOPRESSIN ACETATEUBI Pharma Inc.b01c22dc-eecd-11b2-e053-2a95a90a529a2025-02-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATEBryant Ranch Prepack52133714-37d1-458d-9839-f0bd206711ea2025-01-31Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATENordic Pharma, Inc.c01048e8-d28f-4085-9c37-3d5d48395a772024-12-06Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATEDESMOPRESSIN ACETATEUBI Pharma Inc.b2fad59d-6176-4e09-9fbb-5cdd7f8f15682024-09-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATEAurobindo Pharma Limited24866ad0-94db-46a2-96c0-b362acd0271a2024-03-25Warnings, Adverse reactionsName fallback
generic name: DESMOPRESSIN ACETATE
Desmopressin AcetateDESMOPRESSIN ACETATEXGen Pharmaceuticals DJB, Inc.1052a869-b64d-655d-e063-6294a90ad0e22024-03-22Boxed warning, Warnings, Adverse reactionsName 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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55566-2400DDAVPDesmopressin AcetateFerring Pharmaceuticals Inc.NDACurrent
55566-2400DDAVPDesmopressin AcetateFerring Pharmaceuticals Inc.NDACurrent
55566-2400DDAVPDesmopressin AcetateFerring Pharmaceuticals Inc.NDACurrent
55566-2400DDAVPDesmopressin AcetateFerring Pharmaceuticals Inc.NDACurrent
55566-2400DDAVPDesmopressin AcetateFerring Pharmaceuticals Inc.NDACurrent
55566-2500DDAVPDesmopressin AcetateFerring Pharmaceuticals Inc.NDACurrent
55566-2500DDAVPDesmopressin AcetateFerring Pharmaceuticals Inc.NDACurrent
55566-2500DDAVPDesmopressin AcetateFerring Pharmaceuticals Inc.NDACurrent
55566-2500DDAVPDesmopressin AcetateFerring Pharmaceuticals Inc.NDACurrent
55566-2500DDAVPDesmopressin AcetateFerring Pharmaceuticals Inc.NDACurrent
69918-501Desmopressin AcetateDesmopressin AcetateAmring Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
69918-501Desmopressin AcetateDesmopressin AcetateAmring Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
69918-501Desmopressin AcetateDesmopressin AcetateAmring Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
69918-501Desmopressin AcetateDesmopressin AcetateAmring Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56090SUPPL2018-10-24
56085SUPPL2018-10-23
33371SUPPL2015-11-19
749SUPPL2015-11-09
44015ORIG2007-12-04
13955SUPPL2007-11-08
11094SUPPL2007-11-07
13954SUPPL2005-11-17
33370SUPPL2005-11-16
748SUPPL2003-11-25