FDA.reportPublic FDA data

Application 021212

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAVERJECT IMPULSEALPROSTADILINJECTABLE;INJECTION0.01MG/VIALNoNo
002CAVERJECT IMPULSEALPROSTADILINJECTABLE;INJECTION0.02MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-5181Caverject ImpulseAlprostadilPharmacia and Upjohn Company LLCNDACurrent
0009-5181Caverject ImpulseAlprostadilPharmacia and Upjohn Company LLCNDACurrent
0009-5182Caverject ImpulseAlprostadilPharmacia and Upjohn Company LLCNDACurrent
0009-5182Caverject ImpulseAlprostadilPharmacia and Upjohn Company LLCNDACurrent
63539-121Caverject ImpulseAlprostadilU.S. PharmaceuticalsNDACurrent
63539-221Caverject ImpulseAlprostadilU.S. PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73051SUPPL2022-12-27
73039SUPPL2022-12-27
45756SUPPL2016-11-01
45755SUPPL2016-11-01
45702SUPPL2016-10-28
45701SUPPL2016-10-28
14642SUPPL2016-05-06
4649SUPPL2016-05-06
36365SUPPL2015-11-04
27082SUPPL2015-10-28
27081SUPPL2014-06-12
14641SUPPL2013-12-23
27080SUPPL2013-12-20
4648SUPPL2003-09-09
36364ORIG2002-06-11
21511ORIG2002-06-11
4647ORIG2002-06-11