FDA.reportPublic FDA data

Application 014879

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOPRAMDOXAPRAM HYDROCHLORIDEINJECTABLE;INJECTION20MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6018DopramDoxapram hydrochlorideWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6018DopramDoxapram hydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
51662-1404DOXAPRAM HYDROCHLORIDEDOXAPRAM HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1404DOXAPRAM HYDROCHLORIDEDOXAPRAM HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40696SUPPL2007-07-09
387SUPPL2006-04-05
10849SUPPL2005-03-23
388SUPPL2005-03-23
33126SUPPL2004-05-03
12073SUPPL2004-04-20
386SUPPL2001-08-23