FDA.reportPublic FDA data

Application 020355

Type
NDA
Sponsor
FERRING PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STIMATEDESMOPRESSIN ACETATESPRAY, METERED;NASAL0.15MG/SPRAYNoNo
002STIMATE (NEEDS NO REFRIGERATION)DESMOPRESSIN ACETATESPRAY, METERED;NASAL0.15MG/SPRAYYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020355-001STIMATEDESMOPRESSIN ACETATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-07
N020355-002STIMATE (NEEDS NO REFRIGERATION)DESMOPRESSIN ACETATE0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-07caaa826d4ba7…
2026-08-18 06:07:402026-07N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD, RS2007-10-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020355-001STIMATE0.15MG/SPRAYSPRAY, METERED / NASAL1994-03-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020355-002STIMATE (NEEDS NO REFRIGERATION)0.15MG/SPRAYSPRAY, METERED / NASALRLD2007-10-24bb7c543d1eb4…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StimateDESMOPRESSIN ACETATEFerring Pharmaceuticals Inc.f5ada39c-20ed-4500-9dce-1e4ab642a3582026-07-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 020355
application number: NDA020355

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0053-6871StimateDESMOPRESSIN ACETATECSL Behring LLCNDACurrent
0053-6871StimateDESMOPRESSIN ACETATECSL Behring LLCNDACurrent
0053-6871StimateDESMOPRESSIN ACETATECSL Behring LLCNDACurrent
0053-6871StimateDESMOPRESSIN ACETATECSL Behring LLCNDACurrent
0053-6871StimateDESMOPRESSIN ACETATECSL Behring LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24812SUPPL2013-06-12
34534SUPPL2013-06-10
12467SUPPL2013-06-04
2367SUPPL2013-05-28
2366SUPPL2011-09-21
34533SUPPL2011-09-20
23577ORIG2007-12-04
24811SUPPL2007-11-08
12466SUPPL2007-11-07
24810SUPPL2002-08-21