FDA.reportPublic FDA data

Application 019281

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYKLOKAPRONTRANEXAMIC ACIDINJECTABLE;INJECTION100MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0013-1114Cyklokaprontranexamic acidPfizer Laboratories Div Pfizer IncNDACurrent
0013-1114Cyklokaprontranexamic acidPharmacia and Upjohn Company LLCNDACurrent
0013-1114Cyklokaprontranexamic acidPharmacia and Upjohn Company LLCNDACurrent
0013-1114Cyklokaprontranexamic acidPharmacia and Upjohn Company LLCNDACurrent
0013-1114Cyklokaprontranexamic acidPfizer Laboratories Div Pfizer IncNDACurrent
0013-1114Cyklokaprontranexamic acidPfizer Laboratories Div Pfizer IncNDACurrent
0013-1114Cyklokaprontranexamic acidPharmacia & Upjohn Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83265SUPPL 2025-09-03
83252SUPPL 2025-09-02
66120SUPPL2021-02-08
66112SUPPL2021-02-05
63578SUPPL2020-06-16
63441SUPPL2020-06-08
63433SUPPL2020-06-08
50495SUPPL2017-11-27
50473SUPPL2017-11-22
33717SUPPL2015-04-14
11467SUPPL2013-05-14
1271SUPPL2013-05-14
17348SUPPL2011-02-02
33716SUPPL2011-01-31
17347SUPPL2009-01-30
33715SUPPL2009-01-02
17346SUPPL2008-12-24
40883SUPPL2001-06-18
1270SUPPL2001-03-27
1269SUPPL1999-09-09