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

NDC Listings For This Application#

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