FDA.reportPublic FDA data

Application 019886

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYNARELNAFARELIN ACETATESPRAY, METERED;NASALEQ 0.2MG BASE/SPRAYYesYes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019886-001SYNARELNAFARELIN ACETATEEQ 0.2MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS1990-02-13

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019886-001SYNARELEQ 0.2MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS1990-02-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019886-001SYNARELEQ 0.2MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS1990-02-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019886-001SYNARELEQ 0.2MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS1990-02-13cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019886-001SYNARELEQ 0.2MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS1990-02-13a50c72e98297…

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
SynarelNAFARELIN ACETATEPfizer Laboratories Div Pfizer Incd0aa57cb-d2f4-46d7-af43-7c8b06aa81a62026-03-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 019886
application number: NDA019886
ndc (product): 0025-0166

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-0166Synarelnafarelin acetatePfizer Laboratories Div Pfizer IncNDACurrent
0025-0166Synarelnafarelin acetatePfizer Laboratories Div Pfizer IncNDACurrent
0025-0166Synarelnafarelin acetatePfizer Laboratories Div Pfizer IncNDACurrent
0025-0166Synarelnafarelin acetateG.D. Searle LLC Division of Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84310SUPPL 2025-11-25
84303SUPPL 2025-11-25
84302SUPPL 2025-11-25
73402SUPPL 2023-02-07
73355SUPPL 2023-02-01
70831SUPPL2022-04-27
70830SUPPL2022-04-27
70807SUPPL2022-04-26
48496SUPPL2017-05-23
48495SUPPL2017-05-23
48480SUPPL2017-05-22
48479SUPPL2017-05-22
48478SUPPL2017-05-22
48477SUPPL2017-05-22
19793SUPPL2015-08-11
11814SUPPL2015-08-10
1764SUPPL2012-01-17
34068SUPPL2012-01-12
34067SUPPL2011-01-11
11813SUPPL2011-01-11
19792SUPPL2011-01-07
1763SUPPL2011-01-07
34066SUPPL2006-04-13
1762SUPPL2006-04-13
20406SUPPL1999-07-21
1761SUPPL1998-12-24